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
193–216 of 245
Cleared Sep 14, 1982
ALBUMIN STANDARD, #65070
K822478
Emd Chemicals, Inc.
Chemistry · 28d
Cleared Sep 14, 1982
BILIRUBIN CALIBRATOR #65071
K822479
Emd Chemicals, Inc.
Chemistry · 28d
Cleared Sep 02, 1982
BILIRUBIN CALIBRATORS
K822334
Gilford Diagnostics
Chemistry · 29d
Cleared Dec 11, 1980
CHOLESTEROL STANDARDS
K802823
Mallinckrodt Critical Care
Chemistry · 31d
Cleared Apr 21, 1980
SLAVO CHOLESTEROL STAND. DIAGNOSTIC KIT
K800770
Sclavo, Inc.
Chemistry · 14d
Cleared Feb 26, 1980
CALIBRATOR NO. 1 & 2, & WASH SOLUTION
K800220
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Dec 06, 1979
TSH STANDARDS & DILUENT
K792290
Amersham Corp.
Chemistry · 23d
Cleared Aug 31, 1978
DUAL COMPONENT STANDARDS
K781423
Abbott Laboratories
Chemistry · 14d
Cleared Aug 14, 1978
T3 STANDARDS IN HUMAN SERUM
K781069
Pcl-Ria, Inc.
Chemistry · 49d
Cleared Aug 14, 1978
STANDARDS, HORMONE, THYROID STIMULATING
K781071
Pcl-Ria, Inc.
Chemistry · 49d
Cleared Jun 22, 1978
URIC ACID REFERENCE SERA
K780447
Macomb Chemical Co.
Chemistry · 94d
Cleared Apr 05, 1978
CALIBRATORS, CARBON DIOXIDE
K780295
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 43d
Cleared Dec 06, 1977
PH CALIBRATION BUFFERS
K772106
General Diagnostics
Chemistry · 29d
Cleared Oct 25, 1977
ACA TRIGLYCERIDE CALIBRATOR
K771797
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 32d
Cleared Oct 25, 1977
ACA CARBON DIOXIDE CALIBRATOR
K771801
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 32d
Cleared Oct 25, 1977
ACA IRON CALIBRATOR
K771802
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 32d
Cleared Oct 25, 1977
ACA PHOSPHORUS CALIBRATOR
K771803
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 32d
Cleared Oct 25, 1977
ACA AMMONIA CALIBRATOR
K771804
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 32d
Cleared Jul 21, 1977
CENTRIFICHEM TRIGLYCERIDE CALI. STD.
K771215
Union Carbide Corp.
Chemistry · 16d
Cleared Jul 21, 1977
CENTRIFICHEM TRIGLYCEOIDE CALI, STD. SET
K771216
Union Carbide Corp.
Chemistry · 16d
Cleared Jan 31, 1977
CENTRIFICHEM CHOLES. CALIB. STD. SET
K770126
Union Carbide Corp.
Chemistry · 10d
Cleared Jan 31, 1977
CENTRIFICHEM 200MG/DL CHOL. CAL. STD.
K770127
Union Carbide Corp.
Chemistry · 10d
Cleared Dec 21, 1976
CHOLESTEROL CALIBRATOR
K761197
Beckman Instruments, Inc.
Chemistry · 15d
Cleared Oct 05, 1976
BILIRUBIN REF., SIGMA STOCK NO. 605-10
K760349
Sigma Chemical Co.
Chemistry · 64d