Panels › Clinical Chemistry › Product code JJY · Class 1
Multi-Analyte Controls, All Kinds (Assayed)
Regulation 862.1660
0510(k)s in 12 months (673 all time)
2recalls in 12 months (95 all time)
73recalls that name a 510(k)
Top companies in JJY
| Company | 510(k)s | Recalls |
|---|---|---|
| Bio-Rad | 61 | 0 |
| Randox Laboratories Limited | 15 | 31 |
| Medical Analysis Systems, Inc. | 31 | 0 |
| Bio-Rad Laboratories | 26 | 1 |
| Roche Diagnostics | 22 | 4 |
| Cliniqa Corporation | 22 | 0 |
| Aalto Scientific, Ltd. | 19 | 0 |
| Maine Standards Co. | 19 | 0 |
| Boehringer Mannheim Corp. | 17 | 0 |
| Casco Standards | 15 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2026 | Microgenics Corporation MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF:
OPRO-101;
MAS Omni IMMUNETM PRO Liquid Assayed Integrated Immunoassay Control, Sample Pack, REF: OPRO-SP Open, Classified |
JJY | None listed |
| Nov 17, 2025 | POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor
FOBT (Fecal Occult Blood Test) Open, Classified |
JJY | K924061 |
| Oct 30, 2025 | Microgenics Corporation Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagn Open, Classified |
JJY | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL. Open, Classified |
JJY | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL. Open, Classified |
JJY | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL Open, Classified |
JJY | None listed |
| Mar 22, 2024 | Ortho-Clinical Diagnostics VITROS Performance Verifier II Open, Classified |
JJY | None listed |
| Mar 22, 2024 | Ortho-Clinical Diagnostics VITROS Performance Verifier I Open, Classified |
JJY | None listed |
| Mar 19, 2024 | Mckesson Medical-Surgical Inc. Corporate Office Abbott Point of Care Control Control i-STAT Level 3 1.7 mL Open, Classified |
JJY | K972868 |
| Mar 19, 2024 | Mckesson Medical-Surgical Inc. Corporate Office Abbott Point of Care Control Control i-STAT Level 1 10 X 1.7 mL Open, Classified |
JJY | K972868 |
| Oct 12, 2023 | TECHNO-PATH MANUFACTURING LTD. Multichem P, Part Code 08P90-10 Open, Classified |
JJY | None listed |
| Oct 12, 2023 | TECHNO-PATH MANUFACTURING LTD. Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19 Open, Classified |
JJY | None listed |
| Oct 12, 2023 | TECHNO-PATH MANUFACTURING LTD. Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12 Open, Classified |
JJY | None listed |
| Sep 19, 2023 | Randox Laboratories Ltd. Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215 Open, Classified |
JJY | K140971 |
| Aug 23, 2023 | Randox Laboratories Ltd. Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG pregnancy, Magnesium, Microalbumin, Open, Classified |
JJY | K110904 |
| Jun 28, 2023 | Randox Laboratories Ltd. Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes
Catalog Number: IA2633 Open, Classified |
JJY | K140522 |
| Jun 28, 2023 | Randox Laboratories Ltd. Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes.
Catalog Number: IA2640 Open, Classified |
JJY | K140522 |
| Jan 5, 2023 | Randox Laboratories Ltd. Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems
Catalog Number: PS2684 Open, Classified |
JJY | K972608 |
| Jan 5, 2023 | Randox Laboratories Ltd. Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems
Catalog Number: PS2683 Open, Classified |
JJY | K972608 |
| Jan 5, 2023 | Randox Laboratories Ltd. Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems
Catalog Number: PS2682
Control Level 1 Open, Classified |
JJY | K972608 |
| May 19, 2022 | Chromsystems Instruments & Chemicals GmbH MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II Terminated |
JJY | None listed |
| May 19, 2022 | Chromsystems Instruments & Chemicals GmbH MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I Terminated |
JJY | None listed |
| Nov 2, 2020 | Chromsystems Instruments & Chemicals GmbH MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of Terminated |
JJY | None listed |
| Nov 2, 2020 | Chromsystems Instruments & Chemicals GmbH MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of Terminated |
JJY | None listed |
| Nov 2, 2020 | Chromsystems Instruments & Chemicals GmbH MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of t Terminated |
JJY | None listed |
| Oct 29, 2020 | Chromsystems Instruments & Chemicals GmbH MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels. Completed |
JJY | None listed |
| Oct 29, 2020 | Chromsystems Instruments & Chemicals GmbH MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels. Completed |
JJY | None listed |
| Oct 16, 2020 | Ortho Clinical Diagnostics Inc VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5, Open, Classified |
JJY | K904768 |
| Jul 28, 2020 | Medline Industries Inc Control, Calibrator Verified, Triage BNP, Model ALR88755 Terminated |
JJY | K072892 |
| Mar 20, 2020 | Utak Laboratories Inc Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label is UTAK LABORATORIES, INC., Valencia, CA. Control for in vitro diagnostics. Terminated |
JJY | K883147 |
| Feb 18, 2020 | Randox Laboratories Ltd. Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for t Open, Classified |
JJY | K140971 |
| Dec 13, 2019 | Randox Laboratories Ltd. Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml Terminated |
JJY | None listed |
| Oct 4, 2019 | Randox Laboratories, Limited Randox Liquid Cardiac Controls Catalogue Numbers CQ5053. Terminated |
JJY | K110534 |
| Oct 4, 2019 | Randox Laboratories, Limited Randox Liquid Cardiac Controls Catalogue Number CQ5052. Terminated |
JJY | K110534 |
| Oct 4, 2019 | Randox Laboratories, Limited Randox Liquid Cardiac Controls Catalogue Number CQ5051 Terminated |
JJY | K110534 |
| Jun 11, 2019 | Randox Laboratories, Limited Human Assayed Multi-Sera Level 2, Model NO. HN1530
Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is f Terminated |
JJY | K942458 |
| Jun 10, 2019 | Randox Laboratories, Limited Assayed Bovine Multi-Sera Level 1, Model No. AL1027 Terminated |
JJY | None listed |
| Apr 9, 2019 | Abbott Laboratories Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for th Terminated |
JJY | K132751 |
| Apr 9, 2019 | Abbott Laboratories Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for th Terminated |
JJY | K132751 |
| Mar 15, 2019 | Response Biomedical Corp. Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318)
IFU: "RAMP Cardiac Controls *** CAT. No.: C2003-2 *** Si Terminated |
JJY | K110534 |
| Mar 11, 2019 | Randox Laboratories Ltd. Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053 Terminated |
JJY | K110534 |
| Feb 13, 2019 | Randox Laboratories Ltd. Randox Blood Gas Control Level 2 -Model BG5002.
In-vitro Diagnostic Quality control of Blood Gas analysis
This product is intended for in vitro diagnostic use, in the quality control of Blood Gas ana Terminated |
JJY | K093384 |
| Feb 7, 2019 | Randox Laboratories Ltd. Liquid Immunoassay Premium Controls, Model Number LIA3105
Product Usage:
This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproduc Terminated |
JJY | K112337 |
| Feb 7, 2019 | Randox Laboratories Ltd. Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112
Product Usage:
This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and Terminated |
JJY | K140522 |
| Feb 7, 2019 | Randox Laboratories Ltd. Immunoassay Premium Controls, Model Numbers IA2633 and IA2638
Product Usage:
This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and repr Terminated |
JJY | K040379 |
| Oct 2, 2018 | Randox Laboratories Ltd. Liquid Cardiac Control, CQ5053 Terminated |
JJY | K110534 |
| Oct 2, 2018 | Randox Laboratories Ltd. Liquid Cardiac Control, CQ5052 Terminated |
JJY | K110534 |
| Oct 2, 2018 | Randox Laboratories Ltd. Liquid Cardiac Control, CQ5051 Terminated |
JJY | K110534 |
| Jun 13, 2018 | Randox Laboratories Ltd. Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684 Terminated |
JJY | K972608 |
| Jun 13, 2018 | Randox Laboratories Ltd. Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683 Terminated |
JJY | K972608 |
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