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 Jun 16, 1997
ELECSYS CEA ASSAY
K964368
Boehringer Mannheim Corp.
Immunology · 227d
Cleared Mar 11, 1994
URINARY/CEBROSPINAL FLUID PROTEIN CALIBRATOR
K934843
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 154d
Cleared Mar 29, 1991
CHOLESTEROL CALIBRATOR SET
K910962
Casco Standards
Chemistry · 23d
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 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
Cleared May 26, 1987
PHOSPHOLIPIDS STANDARD SOLUTION CALIBRATOR
K871765
Wako Chemicals USA, Inc.
Chemistry · 21d
Cleared May 26, 1987
TRIGLYCERIDE STANDARD SOLUTION CALIBRATOR
K871766
Wako Chemicals USA, Inc.
Chemistry · 21d
Cleared May 26, 1987
UREA N STANDARD SOLUTION CALIBRATOR
K871767
Wako Chemicals USA, Inc.
Chemistry · 21d