JIT · Class II · 21 CFR 862.1150

FDA Product Code JIT: Calibrator, Secondary

Leading manufacturers include Dade Behring, Inc., Wako Chemicals USA, Inc. and Roche Diagnostics Corp..

245
Total
245
Cleared
59d
Avg days
1976
Since
245 devices
25–48 of 245
Cleared Dec 17, 2010
DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL
K103360
Siemens Corp.
Chemistry · 31d
Cleared Nov 30, 2010
DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS
K102638
Diazyme Laboratories
Chemistry · 77d
Cleared Feb 27, 2009
DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350
K083462
Siemens Healthcare Diagnostics
Chemistry · 95d
Cleared Oct 10, 2008
LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623
K082680
Siemens Healthcare Diagnostics
Chemistry · 25d
Cleared Sep 10, 2008
DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR
K081789
Siemens Healthcare Diagnostics, Inc.
Chemistry · 77d
Cleared Aug 04, 2008
DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56
K081319
Siemens Healthcare Diagnostics, Inc.
Chemistry · 84d
Cleared Jul 07, 2008
LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621
K081683
Siemens Healthcare Diagnostics
Chemistry · 20d
Cleared Mar 19, 2008
ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545
K080166
Beckman Coulter, Inc.
Chemistry · 56d
Cleared Dec 12, 2007
DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210
K072717
Dade Behring, Inc.
Chemistry · 78d
Cleared Apr 30, 2007
DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR)
K070552
Dade Behring, Inc.
Immunology · 62d
Cleared Feb 01, 2007
INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS
K070144
Beckman Coulter, Inc.
Chemistry · 16d
Cleared Aug 16, 2006
CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27
K062152
Dade Behring, Inc.
Chemistry · 20d
Cleared Aug 14, 2006
DIMENSION VISTA SYSTEM TOTAL TRIIODOTHYRONINE CALIBRATOR, MODEL KC250
K061885
Dade Behring, Inc.
Chemistry · 42d
Cleared Jul 18, 2006
DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330)
K061818
Dade Behring, Inc.
Chemistry · 20d
Cleared Jul 13, 2006
DIMENSION VISTA SYSTEM UCFP CALIBRATOR, MODEL KC260
K061751
Dade Behring, Inc.
Chemistry · 22d
Cleared Jul 10, 2006
DIMENSION VISTA SYSTEM CREATINE KINASE CALIBRATOR (CK CAL - KC340)
K061702
Dade Behring, Inc.
Chemistry · 24d
Cleared Jul 06, 2006
BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS
K061139
Bayer Healthcare, LLC
Immunology · 73d
Cleared Jun 02, 2006
ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585
K061282
Beckman Coulter, Inc.
Chemistry · 25d
Cleared Apr 24, 2006
CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250
K060140
Diagnostic Chemicals , Ltd.
Chemistry · 95d
Cleared Apr 18, 2006
ELECSYS TSH CALSET W/MODELS 04738551
K060754
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Mar 21, 2006
CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED
K060322
Cliniqa Corporation
Chemistry · 40d
Cleared Mar 09, 2006
THE EMIT 2000 TACROLIMUS CALIBRATORS
K060371
Dade Behring, Inc.
Chemistry · 24d
Cleared Feb 07, 2006
DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR
K053576
Dade Behring, Inc.
Chemistry · 47d
Cleared Dec 16, 2005
ARCHITECT B12 CALIBRATORS
K053330
Abbott Laboratories
Chemistry · 15d