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
97–120 of 245
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
Cleared Sep 30, 2002
FASTPACK TESTOSTERONE CALIBRATOR
K022533
Qualigen, Inc.
Chemistry · 61d
Cleared Jul 22, 2002
CALIBRATING MATERIAL, BUFFERS, STANDARD
K022027
Mission Diagnostics
Chemistry · 31d
Cleared Jun 27, 2002
ADVIA CENTAUR AND ACS:180 C-PEPTIDE CALIBRATOR
K021532
Bayer Diagnostics Corp.
Chemistry · 48d
Cleared Jun 27, 2002
ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR
K021535
Bayer Diagnostics Corp.
Chemistry · 48d
Cleared Jun 27, 2002
RDI HS CRP CALIBRATOR SET
K021607
Reference Diagnostics, Inc.
Immunology · 42d
Cleared Jun 21, 2002
DIMENSION TPSA CALIBRATOR, MODEL #RC459
K020980
Dade Behring, Inc.
Immunology · 87d
Cleared May 08, 2002
DIMENSION ALDL CALIBRATOR, MODEL DC131
K020723
Dade Behring, Inc.
Chemistry · 63d
Cleared Apr 29, 2002
CALIBRATING MATERIAL, CAL-PAK, BUFFERS
K020894
Mission Diagnostics
Chemistry · 41d
Cleared Apr 08, 2002
CHEMISTRY CALIBRATOR
K020454
Jas Diagnostics, Inc.
Chemistry · 56d
Cleared Mar 23, 2002
CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDS
K020596
Diamond Diagnostics, Inc.
Chemistry · 29d
Cleared Dec 21, 2001
STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE
K013850
Diamond Diagnostics, Inc.
Chemistry · 31d
Cleared Oct 16, 2001
ACCESS UNCONJUGATED ESTRIOL CALIBRATORS
K012900
Beckman Coulter, Inc.
Chemistry · 48d
Cleared Oct 09, 2001
VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D
K012367
Nichols Institute Diagnostics
Chemistry · 75d
Cleared Sep 11, 2001
STRATUS CS TROPONIN I CALIBRATOR
K012233
Dade Behring, Inc.
Chemistry · 57d
Cleared Aug 24, 2001
MODIFICATION TO ELECSYS FSH II CALSET
K012399
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Aug 01, 2001
WAKO IMMUNOASSAY CALIBRATOR SET
K010332
Wako Chemicals USA, Inc.
Immunology · 180d
Cleared Jun 25, 2001
WAKO LIPID CALIBRATOR
K010334
Wako Chemicals USA, Inc.
Immunology · 143d
Cleared May 02, 2001
RAICHEM CREATININE URINE STANDARD
K011126
Hemagen Diagnostics, Inc.
Chemistry · 19d
Cleared Apr 20, 2001
DIMENSION CTNI CALIBRATOR
K010314
Dade Behring, Inc.
Chemistry · 77d