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
Cleared
May 16, 2017
VITROS Immunodiagnostic Products Insulin Calibrators
Ortho-Clinical Diagnostics
Chemistry
25d
Cleared
Apr 26, 2017
CalSet IGF-1
Roche Diagnostics
Chemistry
27d
Cleared
Feb 15, 2017
Abbott ARCHITECT Free T3
Abbott Laboratories
Chemistry
28d
Cleared
Jan 13, 2017
Lumipulse G FSH-N Calibrators
Fujirebio Diagnostics,Inc.
Chemistry
28d
Cleared
Jan 13, 2017
Lumipulse G Progesterone-N Calibrators
Fujirebio Diagnostics,Inc.
Chemistry
28d
Cleared
Jan 12, 2017
Lumipulse G LH Calibrators
Fujirebio Diagnostics,Inc.
Chemistry
28d
Cleared
Jan 12, 2017
Lumipulse G Prolactin
Fujirebio Diagnostics,Inc.
Chemistry
27d
Cleared
Dec 08, 2016
DC-UIBC-CAL
Sekisui Diagnostics P.E.I., Inc.
Chemistry
35d
Cleared
Dec 01, 2016
Lumipulse G E2-III Calibrators
Fujirebio Diagnostics,Inc.
Chemistry
30d
Cleared
Nov 17, 2016
ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator
Siemens Healthcare Diagnostics
Chemistry
66d
Cleared
Feb 17, 2016
ST AIA-PACK hsE2 Calibrator Set
Tosoh Bioscience, Inc.
Chemistry
29d
Cleared
Dec 18, 2015
ST AIA-PACK PROG III Calibrator Set
Tosoh Bioscience, Inc.
Chemistry
23d
Cleared
Oct 02, 2015
Elecsys Progesterone III CalSet
Roche Diagnostics
Chemistry
29d
Cleared
Jul 10, 2015
Abbott ARCHITECT Total T4 Calibrators
Abbott Laboratories
Chemistry
30d
Cleared
Feb 26, 2015
UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator
Beckman Coulter, Inc.
Chemistry
133d
Cleared
Dec 19, 2014
Elecsys T-Uptake Calset
Roche Diagnostics
Chemistry
28d
Cleared
Dec 03, 2014
ST AIA-PACK PROG II Calibrator Set
Tosoh Bioscience, Inc.
Chemistry
30d
Cleared
Sep 18, 2014
RANDOX ALDOLASE CALIBRATION SERUM
Randox Laboratories Limited
Chemistry
41d
Cleared
Aug 12, 2014
Elecsys Estradiol III CalSet
Roche Diagnostics
Chemistry
18d
Cleared
Aug 08, 2014
DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS
Diamond Diagnostics, Inc.
Chemistry
242d
Cleared
Jul 28, 2014
ACE CALIBRATOR
SENTINEL CH. SpA
Chemistry
32d
Cleared
Jun 30, 2014
BICARBONATE CALIBRATOR
Beckman Coulter Ireland, Inc.
Chemistry
34d
Cleared
Jun 06, 2014
CA 125 II CALSET II
Roche Diagnostics
Immunology
142d
Cleared
Apr 10, 2014
ST AIA-PACK C-PEPTIDE II CALIBRATOR SET
Tosoh Bioscience, Inc.
Chemistry
28d