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
145–168 of 245
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 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