JIT · Class II · 21 CFR 862.1150

FDA Product Code JIT: Calibrator, Secondary

Leading manufacturers include Dade Behring, Inc., Roche Diagnostics Corp. and E.I. Dupont DE Nemours & Co., Inc..

245
Total
245
Cleared
59d
Avg days
1976
Since

FDA 510(k) Cleared Calibrator, Secondary Devices (Product Code JIT)

245 devices
1–24 of 245
Cleared Apr 26, 2017
CalSet IGF-1
K170938
Roche Diagnostics
Chemistry · 27d
Cleared Feb 15, 2017
Abbott ARCHITECT Free T3
K170160
Abbott Laboratories
Chemistry · 28d
Cleared Jul 10, 2015
Abbott ARCHITECT Total T4 Calibrators
K151566
Abbott Laboratories
Chemistry · 30d
Cleared Feb 26, 2015
UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator
K142985
Beckman Coulter, Inc.
Chemistry · 133d
Cleared Aug 19, 2011
ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033
K111952
Beckman Coulter, Inc.
Chemistry · 39d
Cleared Jun 10, 2011
ABBOTT ARCHITECT LH CALIBRATORS
K111023
Abbott Laboratories
Chemistry · 58d
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 Jun 02, 2006
ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585
K061282
Beckman Coulter, Inc.
Chemistry · 25d
Cleared Apr 18, 2006
ELECSYS TSH CALSET W/MODELS 04738551
K060754
Roche Diagnostics Corp.
Chemistry · 28d
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
Cleared Aug 22, 2005
IRON STANDARD
K052002
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Jul 06, 2005
ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET
K050231
Roche Diagnostics Corp.
Immunology · 161d
Cleared Nov 23, 2004
ROCHE DIAGNOSTICS ELECSYS AFP CALSET II
K043095
Roche Diagnostics Corp.
Immunology · 14d
Cleared Oct 05, 2004
FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
K042651
Beckman Coulter, Inc.
Toxicology · 7d

About Product Code JIT - Regulatory Context