Company · US
Instrumentation Laboratory CO
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 2023. Name variants (Inc, Corp, punctuation) are merged.
327510(k) clearances (0 in 12 months)
106recalls (32 in 12 months)
103recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 51 |
| GKP | Instrument, Coagulation, Automated | 36 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 30 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 23 |
| GJS | Test, Time, Prothrombin | 19 |
| KFF | Assay, Heparin | 13 |
| CGA | Glucose Oxidase, Glucose | 11 |
| GGN | Plasma, Coagulation Control | 11 |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 10 |
| GJT | Plasma, Coagulation Factor Deficient | 10 |
| JBQ | Antithrombin Iii Quantitation | 9 |
| GFO | Activated Partial Thromboplastin | 6 |
| CEM | Electrode, Ion Specific, Potassium | 5 |
| JGS | Electrode, Ion Specific, Sodium | 5 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 5 |
| JXR | Atomic Absorption Spectrophotometer, General Use | 5 |
| GKL | Counter, Cell, Automated (Particle Counter) | 4 |
| JIX | Calibrator, Multi-Analyte Mixture | 4 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 4 |
| LCO | Platelet Factor 4 Radioimmunoassay | 4 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 29, 2023 | K233790 | ACL TOP 970 CL Instrumentation Laboratory | JPA |
| Dec 13, 2023 | K230852 | HemosIL Chromogenic Factor IX Instrumentation Laboratory Company | GGP |
| Sep 29, 2023 | K221359 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM Instrumentation Laboratory CO | JPA |
| Aug 10, 2023 | K223608 | GEM Premier 7000 with IQM3 Instrumentation Laboratory Company | CHL |
| Jun 23, 2023 | K223187 | HemosIL Liquid Anti-Xa Instrumentation Laboratory CO | QLU |
| Jun 21, 2023 | K231031 | ACL TOP Family 70 Series Instrumentation Laboratory Company | GKP |
| Jan 27, 2023 | K223090 | GEM Premier ChemSTAT Instrumentation Laboratory CO | CGA |
| Dec 9, 2022 | K223402 | HemosIL von Willebrand Factor Antigen Instrumentation Laboratory CO | GGP |
| Oct 4, 2022 | K213464 | HemosIL Liquid Anti-Xa Instrumentation Laboratory CO | KFF |
| Aug 16, 2022 | K213426 | HemosIL ReadiPlasTin Instrumentation Laboratory CO | GJS |
| Aug 20, 2021 | K203790 | GEM Premier 5000 Instrumentation Laboratory CO | CHL |
| Sep 17, 2020 | DEN190032 | HemosIL Liquid Anti-Xa Instrumentation Laboratory CO | QLU |
| Aug 19, 2020 | K200033 | HemosIL von Willebrand Factor Antigen Instrumentation Laboratory CO | GGP |
| Feb 16, 2019 | K183555 | GEM Premier ChemSTAT Instrumentation Laboratory CO | JFY |
| Feb 16, 2019 | K183549 | GEM Premier ChemSTAT Instrumentation Laboratory CO | JGS |
| Feb 16, 2019 | K183546 | GEM Premier ChemSTAT Instrumentation Laboratory CO | CGA |
| Mar 22, 2018 | K180486 | HemosIL Factor XII Deficient Plasma Instrumentation Laboratory CO | GJT |
| Dec 29, 2017 | K173403 | GEM Premier 5000 Instrumentation Laboratory CO | CHL |
| Nov 22, 2017 | K172903 | HemosIL D-Dimer HS 500 Instrumentation Laboratory CO | DAP |
| Sep 8, 2017 | K170854 | HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls Instrumentation Laboratory CO | LCO |
| Mar 3, 2017 | K170314 | ACL AcuStar Instrumentation Laboratory CO | JPA |
| Dec 14, 2016 | K160415 | GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Instrumentation Laboratory CO | GKF |
| Dec 14, 2016 | K160412 | GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) Instrumentation Laboratory CO | CHL |
| Dec 14, 2016 | K160402 | GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) Instrumentation Laboratory CO | CGA |
| Dec 14, 2016 | K160225 | GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluat Instrumentation Laboratory CO | JGS |
| Oct 27, 2016 | K160885 | HemosIL D-Dimer HS Instrumentation Laboratory CO | DAP |
| Sep 14, 2016 | K161818 | GEM Premier 3000 Instrumentation Laboratory CO | CGA |
| Jul 8, 2016 | K153137 | HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls Instrumentation Laboratory CO | LCO |
| Mar 16, 2016 | K160445 | HemosIL Silica Clotting Time Instrumentation Laboratory CO | GFO |
| Mar 3, 2016 | K160276 | ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) Instrumentation Laboratory CO | GKP |
| Dec 13, 2015 | K150877 | ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS Instrumentation Laboratory CO | GKP |
| Jul 6, 2015 | K151534 | HemosIL D-Dimer HS Instrumentation Laboratory CO | DAP |
| Aug 15, 2014 | K133582 | HEMOSIL D-DIMER HS 500 CONTROL Instrumentation Laboratory | GGN |
| Mar 13, 2014 | K133005 | HEMOSIL VON WILLEBRAND ACTIVITY ASSAY Instrumentation Laboratory CO | GGP |
| Jan 22, 2014 | K132722 | HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL) Instrumentation Laboratory CO | GJS |
| Jan 13, 2014 | K133407 | GEM PREMIER 4000 Instrumentation Laboratory CO | CHL |
| Mar 24, 2013 | K122584 | HEMOSIL READIPLAS TIN Instrumentation Laboratory CO | GJS |
| May 3, 2012 | K112995 | GEM PREMIER 4000 Instrumentation Laboratory CO | CEM |
| Jan 4, 2012 | K113211 | HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL Instrumentation Laboratory CO | GGN |
| Aug 24, 2011 | K110031 | HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM Instrumentation Laboratory CO | GIR |
| Jul 8, 2011 | K110237 | HEMOSIL FACTOR VIII DEFICIENT PLASMA Instrumentation Laboratory CO | GJT |
| Apr 5, 2011 | K102552 | HEMOSIL LA POSITIVE CONTROL Instrumentation Laboratory CO | GGC |
| Mar 17, 2011 | K102164 | HEMOSIL PROTEIN S ACTIVITY ASSAY Instrumentation Laboratory CO | GGP |
| Jun 18, 2010 | K093623 | GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO Instrumentation Laboratory CO | CIG |
| May 21, 2010 | K091556 | HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS Instrumentation Laboratory CO | MSV |
| May 4, 2010 | K093737 | HEMOSIL F11 & FV DNA CONTROL Instrumentation Laboratory CO | NZB |
| Mar 11, 2010 | K092181 | HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS Instrumentation Laboratory CO | MID |
| Feb 5, 2010 | K090264 | HEMOSIL D-DIMER HS 500, CONTROLS Instrumentation Laboratory CO | DAP |
| Oct 9, 2009 | K090563 | HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE) Instrumentation Laboratory CO | GGN |
| Sep 22, 2009 | K091980 | ACL TOP 700 LAS Instrumentation Laboratory CO | GKP |
Newest 50 of 327.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2026 | Instrumentation Laboratory HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only) Open, Classified |
LCO | K170854 |
| Oct 10, 2026 | Instrumentation Laboratory HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic Open, Classified |
LCO | K170854 |
| Aug 6, 2026 | Instrumentation Laboratory GEM Premier 5000 PAK
Part Numbers:
00055360010
00055360011
00055407504
00055415010
00055430010
00055430011
00055445010
00055445011
00055360010.A Open, Classified |
CHL | K203790 |
| Aug 6, 2026 | Instrumentation Laboratory GEM Premier 7000 with iQM3
Part Numbers:
00077407508
00077407510
00077415004
00077415008
00077415010
00077430010
Product Description: The GEM Premier 7000 with iQM3 is a portable critical care sys Open, Classified |
CHL | K223608 |
| Jul 29, 2026 | Instrumentation Laboratory Brand Name: GEM Premier 5000
Product Name: GEM Premier 5000
Model/Catalog Number: 00024019255
Portable blood analyzer system Open, Classified |
CHL | K203790 |
| Jul 29, 2026 | Instrumentation Laboratory Brand Name: GEM Premier 5000
Product Name: GEM Premier 5000
Model/Catalog Number: 00024019255
Portable blood analyzer system Open, Classified |
CHL | K203790 |
| Jul 29, 2026 | Instrumentation Laboratory Brand Name: GEM Premier 5000
Product Name: GEM Premier 5000
Model/Catalog Number: 00024019255
portable blood analyzer system Open, Classified |
CHL | K203790 |
| Jul 29, 2026 | Instrumentation Laboratory Brand Name: GEM Premier 5000
Product Name: GEM Premier 5000
Model/Catalog Number: 00024019255
portable blood analyzer system Open, Classified |
CHL | K203790 |
| Jul 29, 2026 | Instrumentation Laboratory Brand Name: GEM Premier 7000 with iQM3
Product Name: GEM Premier 7000 with iQM3
Model/Catalog Number: 00000015279
Intelligent Quality Management 3 (iQM3) is used as the quality control (QC) and asses Open, Classified |
CHL | K223608 |
| Jul 29, 2026 | Instrumentation Laboratory GEM Premier 5000 with IQM2
Model/Catalog Number: 00024019255 and
GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279
Portable blood analyzer system.
Affected Accessory:
Bar Code Read Open, Classified |
CHL | K203790 |
| Mar 10, 2026 | Instrumentation Laboratory GEM Premier 5000; Part No. 00055445010 & 00055445011. Open, Classified |
CHL | K203790 |
| Mar 10, 2026 | Instrumentation Laboratory GEM Premier 5000; Part No. 00055445008. Open, Classified |
CHL | K203790 |
| Mar 10, 2026 | Instrumentation Laboratory GEM Premier 5000; Part No. 00055445004. Open, Classified |
CHL | K203790 |
| Mar 10, 2026 | Instrumentation Laboratory GEM Premier 5000; Part No. 00055430011. Open, Classified |
CHL | K203790 |
| Mar 10, 2026 | Instrumentation Laboratory GEM Premier 5000; Model No. 00055430010. Open, Classified |
CHL | K203790 |
| Mar 10, 2026 | Instrumentation Laboratory GEM Premier 5000; Part No. 00055430008. Open, Classified |
CHL | K203790 |
| Mar 10, 2026 | Instrumentation Laboratory GEM Premier 5000; Part No. 00055430004. Open, Classified |
CHL | K203790 |
| Mar 10, 2026 | Instrumentation Laboratory GEM Premier 5000; Part No: 00055415011. Open, Classified |
CHL | K203790 |
| Mar 10, 2026 | Instrumentation Laboratory GEM Premier 5000; Part No. 00055415010. Open, Classified |
CHL | K160412 |
| Mar 10, 2026 | Instrumentation Laboratory GEM Premier 5000; Part No. 00055415008. Open, Classified |
CHL | K203790 |
| Mar 10, 2026 | Instrumentation Laboratory GEM Premier 5000; Part No. 00055415005. Open, Classified |
CHL | K203790 |
| Mar 10, 2026 | Instrumentation Laboratory GEM Premier 5000 PAK; Part No. 00055415004. Open, Classified |
CHL | K203790 |
| Mar 10, 2026 | Instrumentation Laboratory GEM Premier 5000 PAK; Part No. 00055407511. Open, Classified |
CHL | K203790 |
| Mar 10, 2026 | Instrumentation Laboratory GEM Premier 5000 PAK; Part No. 00055407510. Open, Classified |
CHL | K203790 |
| Mar 10, 2026 | Instrumentation Laboratory GEM Premier 5000 PAK; Part No. 00055407508. Open, Classified |
CHL | K203790 |
| Mar 10, 2026 | Instrumentation Laboratory GEM Premier 5000 PAK; Part No. 00055407504. Open, Classified |
CHL | K203790 |
| Mar 10, 2026 | Instrumentation Laboratory GEM Premier 5000 PAK; Part No. 00055360011. Open, Classified |
CHL | K203790 |
| Mar 10, 2026 | Instrumentation Laboratory GEM Premier 5000 PAK; Part No. 00055360010. Open, Classified |
CHL | K203790 |
| Mar 10, 2026 | Instrumentation Laboratory GEM Premier 5000 PAK; Part No. 00055360008. Open, Classified |
CHL | K203790 |
| Mar 10, 2026 | Instrumentation Laboratory GEM Premier 5000 PAK, Part No. 00055360004. Open, Classified |
CHL | K203790 |
| Jan 15, 2026 | Instrumentation Laboratory The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of
heparin therapy. Open, Classified |
GFO | K060688 |
| Dec 17, 2025 | Instrumentation Laboratory HemosIL SynthAFax. Partial Thromboplastin Time Tests. Open, Classified |
GFO | K955638 |
| Aug 13, 2025 | Instrumentation Laboratory HemosIL LMW Heparin Controls;
Part Number: 0020300200; Open, Classified |
KFF | K213464 K980242 |
| Jan 24, 2025 | Instrumentation Laboratory HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic Open, Classified |
KFF | K213464 |
| Sep 30, 2024 | Instrumentation Laboratory ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing.
Part Number: 0001000311R Open, Classified |
KFF | K090209 |
| Sep 30, 2024 | Instrumentation Laboratory ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing.
Part Number: 0000880311R Open, Classified |
KFF | K090209 |
| Sep 30, 2024 | Instrumentation Laboratory ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing.
Part Number: 0001000311 Open, Classified |
KFF | K090209 |
| Sep 30, 2024 | Instrumentation Laboratory ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing.
Part Number: 0000880311 Open, Classified |
KFF | K090209 |
| Nov 21, 2023 | Instrumentation Laboratory GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00024345009, 00024360009 Open, Classified |
CHL | K161818 K992834 |
| Nov 21, 2023 | Instrumentation Laboratory GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007 Open, Classified |
CHL | K161818 K992834 |
| Nov 21, 2023 | Instrumentation Laboratory GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004 Open, Classified |
CHL | K161818 K992834 |
| Sep 12, 2023 | Instrumentation Laboratory ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis Open, Classified |
GKP | K150877 |
| Apr 28, 2022 | Instrumentation Laboratory ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL:
Name Part Number
1.ACL TOP 300 CTS 00000280060
2. ACL TOP 300 CTS 00000280060R (Refurbished)
3. ACL TOP 350 CTS 00000280065
4. ACL TOP 500 CTS 00000 Open, Classified |
GKP | K160276 |
| Apr 8, 2022 | Instrumentation Laboratory HemosIL ReadiPlasTin, Part No. 0020301400 Open, Classified |
GJS | K122584 |
| Nov 23, 2021 | Instrumentation Laboratory HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent. Open, Classified |
GJS | K122584 |
| Aug 25, 2021 | Instrumentation Laboratory HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL C Open, Classified |
N/A | None listed |
| Aug 25, 2021 | Instrumentation Laboratory HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic
use by laboratory professionals in clinical laboratories. The assay provides
quantitative results on 3.2% citrated human pla Open, Classified |
QLU | None listed |
| Aug 25, 2021 | Instrumentation Laboratory HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL C Open, Classified |
KFF | K090209 |
| Jul 23, 2019 | Instrumentation Laboratory Co. ROTEM ex-tem
Rest of the world part No: 503-05 (ROW) Terminated |
JPA | K101533 |
| Jul 23, 2019 | Instrumentation Laboratory Co. ROTEM ex-tem
Canada Part No: 503-05-CA Terminated |
JPA | K101533 |
Newest 50 of 106.