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
73–96 of 245
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 Nov 09, 2005
TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET
K052148
Reference Diagnostics, Inc.
Chemistry · 93d
Cleared Oct 28, 2005
ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET
K052982
Roche Diagnostics
Chemistry · 4d
Cleared Oct 03, 2005
ISE COMPENSATOR
K052193
Roche Diagnostics
Chemistry · 53d
Cleared Aug 22, 2005
IRON STANDARD
K052002
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Jul 19, 2005
PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML.
K051012
Salimetrics, LLC
Chemistry · 89d
Cleared Jul 06, 2005
ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET
K050231
Roche Diagnostics Corp.
Immunology · 161d
Cleared Dec 29, 2004
DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT
K043378
Drew Scientific , Ltd.
Chemistry · 21d
Cleared Dec 09, 2004
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23
K042838
Ortho-Clinical Diagnostics, Inc.
Chemistry · 56d
Cleared Dec 03, 2004
OLYMPUS LACTATE, OSR6193
K042406
Olympus America, Inc.
Chemistry · 91d
Cleared Nov 23, 2004
ROCHE DIAGNOSTICS ELECSYS AFP CALSET II
K043095
Roche Diagnostics Corp.
Immunology · 14d
Cleared Nov 18, 2004
VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 AND APOA1 AND APOB PERFORMANCE VERIFIERS
K042521
Ortho-Clinical Diagnostics, Inc.
Chemistry · 63d
Cleared Nov 03, 2004
ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH)
K042307
Seradyn, Inc.
Chemistry · 70d
Cleared Oct 05, 2004
FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
K042651
Beckman Coulter, Inc.
Toxicology · 7d
Cleared Sep 30, 2004
ELECSYS FOLATE II CALSET II
K042490
Roche Diagnostics Corp.
Chemistry · 16d
Cleared Apr 23, 2004
AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR
K033860
Wako Chemicals USA, Inc.
Chemistry · 133d
Cleared Apr 08, 2004
OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL CALIBRATOR ODC0023
K040692
Olympus America, Inc.
Chemistry · 22d
Cleared Mar 25, 2004
WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SET
K040226
Wako Chemicals USA, Inc.
Chemistry · 52d
Cleared Mar 10, 2004
OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296
K040471
Olympus America, Inc.
Chemistry · 15d
Cleared Mar 04, 2004
CALIBRATING MATERIAL, CALIBRATING STANDARDS
K033060
Diamond Diagnostics, Inc.
Chemistry · 157d
Cleared Feb 27, 2004
LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVA
K033786
Ibl GmbH
Chemistry · 85d
Cleared Jan 08, 2004
CO2 CALIBRATOR/DILUENT
K033643
Bayer Healthcare, Diagnostics Division
Chemistry · 49d
Cleared Oct 06, 2003
ABBOTT ARCHITECT ESTRADIOL CALIBRATORS
K032458
Abbott Laboratories
Chemistry · 56d