DKB · Class II · 21 CFR 862.3200

FDA Product Code DKB: Calibrators, Drug Mixture

Leading manufacturers include Syva Co., Roche Diagnostic Systems, Inc. and Diagnostic Reagents, Inc..

94
Total
94
Cleared
74d
Avg days
1979
Since
94 devices
73–94 of 94
Cleared Jun 11, 1987
4-9295 BARBITURATES TEST MIX
K871174
Supelco, Inc.
Toxicology · 79d
Cleared Sep 26, 1984
EMIT 700 CALIBRATOR B
K843507
Syva Co.
Toxicology · 20d
Cleared Sep 12, 1984
EMIT 700 CALIBRATOR A
K843163
Syva Co.
Toxicology · 33d
Cleared Sep 05, 1984
EMIT D.A.U. LOW & MED. CALIBRATORS B
K842816
Syva Co.
Toxicology · 49d
Cleared Aug 15, 1984
ACA BARBITURATES SCREEN/BENZODIAZEPIN
K842386
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 58d
Cleared Jan 13, 1984
THERAPEUTIC DRUG CONTROL
K833761
Icl Scientific
Toxicology · 79d
Cleared Jan 01, 1984
DRUG STANDARDS
K833276
Supelco, Inc.
Toxicology · 101d
Cleared Jan 05, 1983
ADVANCE SYSTEM EMITAED ANTIEPILEPTIC
K823740
Syva Co.
Chemistry · 23d
Cleared Jun 25, 1982
EMIT ST URINE METHAGUALONE CALIBRATOR
K821767
Syva Co.
Toxicology · 10d
Cleared Mar 11, 1982
EMIT-ST URINE CALIBRATOR A (#3A319
K820461
Syva Co.
Toxicology · 20d
Cleared Feb 12, 1982
CALIBRATOR SET
K820190
Syva Co.
Toxicology · 18d
Cleared Jul 15, 1981
DRUG STANDARDS
K811674
Supelco, Inc.
Chemistry · 30d
Cleared Jun 25, 1981
EMIT-TOX SERUM CALIBRATORS
K811620
Syva Co.
Toxicology · 17d
Cleared Mar 06, 1981
EMIT-ST SERUM CALBRATOR
K810464
Syva Co.
Toxicology · 11d
Cleared Nov 12, 1980
EMIT-STM URINE CALIBRATORS
K802624
Syva Co.
Toxicology · 23d
Cleared May 03, 1979
EMIT-TOX SERUM CALIBRATORS
K790735
Syva Co.
Toxicology · 17d