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
145–168 of 245
Cleared Nov 02, 1994
FLUIDS PACK
K944516
Alko Diagnostic Corp.
Chemistry · 48d
Cleared Mar 11, 1994
URINARY/CEBROSPINAL FLUID PROTEIN CALIBRATOR
K934843
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 154d
Cleared Nov 08, 1991
TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL
K913371
Creative Laboratory Products, Inc.
Chemistry · 102d
Cleared Mar 29, 1991
CHOLESTEROL CALIBRATOR SET
K910962
Casco Standards
Chemistry · 23d
Cleared Feb 27, 1991
ELECTROPHORESIS CONTROL
K910160
Seradyn, Inc.
Chemistry · 43d
Cleared Nov 28, 1990
SECONDARY CALIBRATORS
K904698
Bionostics, Inc.
Chemistry · 43d
Cleared Jan 18, 1990
COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN.
K895648
Ventrex Laboratories, Inc.
Chemistry · 120d
Cleared Jan 18, 1990
COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN.
K895649
Ventrex Laboratories, Inc.
Chemistry · 120d
Cleared Aug 15, 1989
CHLORIDE STANDARDS ITEM #SR1041
K891999
Em Diagnostic Systems, Inc.
Chemistry · 140d
Cleared Jul 20, 1989
DOCUMENT(TM) URIC ACID LINEARITY TEST SET
K893139
Casco Standards
Chemistry · 86d
Cleared Dec 14, 1988
DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET
K884197
Casco Standards
Chemistry · 69d
Cleared Oct 06, 1988
BINAS LUTEINIZING HORMONE IRMA TEST KIT
K883306
Binax, Inc.
Chemistry · 63d
Cleared Jul 21, 1988
DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023
K882259
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 51d
Cleared Dec 14, 1987
PARAMAX ISE CHLORIDE CALIBRATOR
K873743
Baxter Healthcare Corp
Chemistry · 89d
Cleared Sep 29, 1987
G-GT STANDARD CALIBRATOR
K871759
Wako Chemicals USA, Inc.
Chemistry · 147d
Cleared Sep 11, 1987
BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052
K872073
American Monitor Corp.
Chemistry · 105d
Cleared Aug 21, 1987
BILE ACIDS CALIBRATOR
K872451
Sigma Diagnostics, Inc.
Chemistry · 59d
Cleared Jul 22, 1987
TOTAL BILIRUBIN STANDARD CALIBRATOR
K872263
Wako Chemicals USA, Inc.
Chemistry · 40d
Cleared May 27, 1987
CREATININE STANDARD SOLUTION CALIBRATOR
K871756
Wako Chemicals USA, Inc.
Chemistry · 22d
Cleared May 26, 1987
ASTRA(TM) SYSTEMS TRIGLYCERIDES CALIBRATOR 8
K871150
Beckman Instruments, Inc.
Chemistry · 64d
Cleared May 26, 1987
GLUCOSE STANDARD SOLUTION CALIBRATOR
K871758
Wako Chemicals USA, Inc.
Chemistry · 21d
Cleared May 26, 1987
MAGNESIUM STANDARD SOLUTION CALIBRATOR
K871762
Wako Chemicals USA, Inc.
Chemistry · 21d
Cleared May 26, 1987
NEFA STANDARD SOLUTION CALIBRATOR
K871763
Wako Chemicals USA, Inc.
Chemistry · 21d
Cleared May 26, 1987
INORGANIC PHOSPHOROUS STANDARD SOLUTION CALIBRATOR
K871764
Wako Chemicals USA, Inc.
Chemistry · 21d