JIT · Class II · 21 CFR 862.1150

FDA Product Code JIT: Calibrator, Secondary

Leading manufacturers include Dade Behring, Inc., Wako Chemicals USA, Inc. and E.I. Dupont DE Nemours & Co., Inc..

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