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
97–120 of 245
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 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
Cleared Mar 15, 2001
N PROTEIN STANDARD UY CALIBRATOR
K003501
Dade Behring, Inc.
Chemistry · 122d
Cleared Mar 01, 2001
ELECSYS TESTOSTERONE CALSET II
K003411
Roche Diagnostics Corp.
Chemistry · 119d
Cleared Feb 20, 2001
DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137
K010208
Dade Behring, Inc.
Chemistry · 28d
Cleared Jan 26, 2001
ELECSYS FSH CALSET II
K003409
Roche Diagnostics Corp.
Chemistry · 85d
Cleared Nov 20, 2000
ACCESS ULTRASENSITIVE HGH CALIBRATORS
K003098
Beckman Coulter, Inc.
Chemistry · 48d
Cleared May 04, 2000
DIRECT TIBC CALIBRATOR
K000783
Reference Diagnostics, Inc.
Chemistry · 55d
Cleared Mar 01, 2000
DIMENSION SPECIAL PROTEIN CALIBRATOR
K994291
Dade Behring, Inc.
Immunology · 71d
Cleared Oct 04, 1999
GENZYME DIRECT AMYLASE VERIFIER
K993132
Genzyme Corp.
Chemistry · 14d