Panels › Clinical Chemistry › Product code JIT · Class 2
Calibrator, Secondary
Regulation 862.1150
0510(k)s in 12 months (245 all time)
1recalls in 12 months (55 all time)
40recalls that name a 510(k)
Top companies in JIT
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 16, 2017 | K171168 | VITROS Immunodiagnostic Products Insulin Calibrators Ortho Clinical Diagnostics | JIT |
| Apr 26, 2017 | K170938 | CalSet IGF-1 Roche Diagnostics | JIT |
| Feb 15, 2017 | K170160 | Abbott ARCHITECT Free T3 Abbott Laboratories | JIT |
| Jan 13, 2017 | K163546 | Lumipulse G Progesterone-N Calibrators Fujirebio Diagnostics,Inc. | JIT |
| Jan 13, 2017 | K163534 | Lumipulse G FSH-N Calibrators Fujirebio Diagnostics,Inc. | JIT |
| Jan 12, 2017 | K163544 | Lumipulse G Prolactin Fujirebio Diagnostics,Inc. | JIT |
| Jan 12, 2017 | K163521 | Lumipulse G LH Calibrators Fujirebio Diagnostics,Inc. | JIT |
| Dec 8, 2016 | K163078 | DC-UIBC-CAL Sekisui Diagnostics P.E.I., Inc., CA | JIT |
| Dec 1, 2016 | K163053 | Lumipulse G E2-III Calibrators Fujirebio Diagnostics,Inc. | JIT |
| Nov 17, 2016 | K162538 | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator Siemens Healthcare Diagnostics | JIT |
| Feb 17, 2016 | K160113 | ST AIA-PACK hsE2 Calibrator Set Tosoh Bioscience, Inc. | JIT |
| Dec 18, 2015 | K153417 | ST AIA-PACK PROG III Calibrator Set Tosoh Bioscience, Inc. | JIT |
| Oct 2, 2015 | K152526 | Elecsys Progesterone III CalSet Roche Diagnostics | JIT |
| Jul 10, 2015 | K151566 | Abbott ARCHITECT Total T4 Calibrators Abbott Laboratories | JIT |
| Feb 26, 2015 | K142985 | UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator Beckman Coulter, Inc. | JIT |
| Dec 19, 2014 | K143342 | Elecsys T-Uptake Calset Roche Diagnostics | JIT |
| Dec 3, 2014 | K143144 | ST AIA-PACK PROG II Calibrator Set Tosoh Bioscience, Inc. | JIT |
| Sep 18, 2014 | K142181 | RANDOX ALDOLASE CALIBRATION SERUM Randox Laboratories Limited, GB | JIT |
| Aug 12, 2014 | K142021 | Elecsys Estradiol III CalSet Roche Diagnostics | JIT |
| Aug 8, 2014 | K133751 | DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS Diamond Diagnostics, Inc. | JIT |
| Jul 28, 2014 | K141728 | ACE CALIBRATOR SENTINEL CH. SpA, IT | JIT |
| Jun 30, 2014 | K141374 | BICARBONATE CALIBRATOR Beckman Coulter Ireland, Inc. | JIT |
| Jun 6, 2014 | K140112 | CA 125 II CALSET II Roche Diagnostics | JIT |
| Apr 10, 2014 | K140648 | ST AIA-PACK C-PEPTIDE II CALIBRATOR SET Tosoh Bioscience, Inc. | JIT |
| Mar 27, 2014 | K130603 | PATHFAST CTNL CALIBRATORS Mitsubishi Chemical Medience Corporation | JIT |
| Dec 19, 2013 | K132400 | LP(A) CALIBRATORS, AND LP(A) CONTROLS Biokit, S.A., ES | JIT |
| Oct 4, 2013 | K130628 | PATHFAST CK-MB-II CALIBRATORS Mitsubishi Chemical Medience Corporation | JIT |
| Jun 26, 2013 | K131556 | DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET Diazyme Laboratories | JIT |
| Apr 5, 2013 | K130698 | DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL) Siemens Healthcare Diagnostics | JIT |
| Feb 15, 2013 | K122177 | ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL Elitechgroup | JIT |
| Dec 20, 2012 | K121027 | DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH Diamond Diagnostics, Inc. | JIT |
| Apr 17, 2012 | K120591 | DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2 Diamond Diagnostics, Inc. | JIT |
| Dec 30, 2011 | K113373 | DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL Siemens Healthcare Diagnostics, Inc. | JIT |
| Aug 19, 2011 | K111952 | ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033 Beckman Coulter, Inc. | JIT |
| Aug 5, 2011 | K111762 | ST AIA-PACK DHEA-S CALIBRATOR SET Tosoh Bioscience, Inc. | JIT |
| Jun 10, 2011 | K111023 | ABBOTT ARCHITECT LH CALIBRATORS Abbott Laboratories | JIT |
| Jun 2, 2011 | K103548 | ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491 Siemens Healthcare Diagnostics, Inc. | JIT |
| Apr 7, 2011 | K110169 | DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H Siemens Healthcare Diagnostics | JIT |
| Feb 16, 2011 | K103836 | ENZYME II CALIBRATOR Siemens Healthcare Diagnostics, Inc. | JIT |
| Dec 23, 2010 | K103221 | ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5 Roche Diagnostics | JIT |
| Dec 17, 2010 | K103360 | DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL Siemens Corp. | JIT |
| Nov 30, 2010 | K102638 | DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS Diazyme Laboratories | JIT |
| Aug 2, 2010 | K092937 | STA-HYBRID HEP CALIBRATOR Diagnostica Stago, Inc. | JIT |
| Jun 24, 2010 | K093357 | DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D Diamond Diagnostics, Inc. | JIT |
| Mar 19, 2010 | K100293 | ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810 Siemens Heatlhcare Diagnostics, Inc. | JIT |
| Oct 16, 2009 | K092570 | ABX PENTRA TPU CAL, MODEL A11A01898 HORIBA ABX SAS, FR | JIT |
| Feb 27, 2009 | K083462 | DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350 Siemens Healthcare Diagnostics | JIT |
| Oct 10, 2008 | K082680 | LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623 Siemens Healthcare Diagnostics | JIT |
| Sep 10, 2008 | K081789 | DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR Siemens Healthcare Diagnostics, Inc. | JIT |
| Sep 3, 2008 | K082141 | ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10 Biokit, S.A., ES | JIT |
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