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 Mar 27, 2014
PATHFAST CTNL CALIBRATORS
K130603
Mitsubishi Chemical Medience Corporation
Chemistry · 385d
Cleared Dec 19, 2013
LP(A) CALIBRATORS, AND LP(A) CONTROLS
K132400
Biokit, S.A.
Chemistry · 140d
Cleared Oct 04, 2013
PATHFAST CK-MB-II CALIBRATORS
K130628
Mitsubishi Chemical Medience Corporation
Chemistry · 210d
Cleared Jun 26, 2013
DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET
K131556
Diazyme Laboratories
Chemistry · 28d
Cleared Apr 05, 2013
DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL)
K130698
Siemens Healthcare Diagnostics
Chemistry · 22d
Cleared Feb 15, 2013
ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL
K122177
Elitechgroup
Chemistry · 207d
Cleared Dec 20, 2012
DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH
K121027
Diamond Diagnostics, Inc.
Chemistry · 260d
Cleared Apr 17, 2012
DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2
K120591
Diamond Diagnostics, Inc.
Chemistry · 49d
Cleared Dec 30, 2011
DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL
K113373
Siemens Healthcare Diagnostics, Inc.
Chemistry · 44d
Cleared Aug 19, 2011
ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033
K111952
Beckman Coulter, Inc.
Chemistry · 39d
Cleared Aug 05, 2011
ST AIA-PACK DHEA-S CALIBRATOR SET
K111762
Tosoh Bioscience, Inc.
Chemistry · 43d
Cleared Jun 10, 2011
ABBOTT ARCHITECT LH CALIBRATORS
K111023
Abbott Laboratories
Chemistry · 58d
Cleared Jun 02, 2011
ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491
K103548
Siemens Healthcare Diagnostics, Inc.
Immunology · 181d
Cleared Apr 07, 2011
DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H
K110169
Siemens Healthcare Diagnostics
Chemistry · 77d
Cleared Feb 16, 2011
ENZYME II CALIBRATOR
K103836
Siemens Healthcare Diagnostics, Inc.
Chemistry · 48d
Cleared Dec 23, 2010
ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5
K103221
Roche Diagnostics
Chemistry · 52d
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 Aug 02, 2010
STA-HYBRID HEP CALIBRATOR
K092937
Diagnostica Stago, Inc.
Hematology · 312d
Cleared Jun 24, 2010
DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D
K093357
Diamond Diagnostics, Inc.
Chemistry · 239d
Cleared Oct 16, 2009
ABX PENTRA TPU CAL, MODEL A11A01898
K092570
HORIBA ABX SAS
Chemistry · 56d
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