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
245 devices
73–96 of 245
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 Oct 06, 2003
ABBOTT ARCHITECT ESTRADIOL CALIBRATORS
K032458
Abbott Laboratories
Chemistry · 56d
Cleared Aug 21, 2003
OLYMPUS PREALBUMIN CALIBRATOR, ODR3029
K032285
Olympus America, Inc.
Chemistry · 28d
Cleared Aug 07, 2003
VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1
K031924
Ortho-Clinical Diagnostics
Chemistry · 45d
Cleared Jun 25, 2003
CALIBRATING MATERIAL, CALIBRATING STANDARDS
K031159
Diamond Diagnostics, Inc.
Chemistry · 72d
Cleared May 12, 2003
ELECSYS LH CALSET II
K031299
Roche Diagnostics Corp.
Chemistry · 18d
Cleared Apr 11, 2003
RDI EXTENDED RANGE CRP CALIBRATOR SET
K030772
Reference Diagnostics, Inc.
Immunology · 31d