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

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

245 devices
1–24 of 245
Cleared May 16, 2017
VITROS Immunodiagnostic Products Insulin Calibrators
K171168
Ortho-Clinical Diagnostics
Chemistry · 25d
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 Jan 13, 2017
Lumipulse G FSH-N Calibrators
K163534
Fujirebio Diagnostics,Inc.
Chemistry · 28d
Cleared Jan 13, 2017
Lumipulse G Progesterone-N Calibrators
K163546
Fujirebio Diagnostics,Inc.
Chemistry · 28d
Cleared Jan 12, 2017
Lumipulse G LH Calibrators
K163521
Fujirebio Diagnostics,Inc.
Chemistry · 28d
Cleared Jan 12, 2017
Lumipulse G Prolactin
K163544
Fujirebio Diagnostics,Inc.
Chemistry · 27d
Cleared Dec 01, 2016
Lumipulse G E2-III Calibrators
K163053
Fujirebio Diagnostics,Inc.
Chemistry · 30d
Cleared Nov 17, 2016
ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator
K162538
Siemens Healthcare Diagnostics
Chemistry · 66d
Cleared Oct 02, 2015
Elecsys Progesterone III CalSet
K152526
Roche Diagnostics
Chemistry · 29d
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 Dec 19, 2014
Elecsys T-Uptake Calset
K143342
Roche Diagnostics
Chemistry · 28d
Cleared Aug 12, 2014
Elecsys Estradiol III CalSet
K142021
Roche Diagnostics
Chemistry · 18d
Cleared Jun 06, 2014
CA 125 II CALSET II
K140112
Roche Diagnostics
Immunology · 142d
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 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 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

About Product Code JIT - Regulatory Context