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
25–48 of 94
Cleared Nov 04, 1998
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I
K983209
Beckman Coulter, Inc.
Toxicology · 51d
Cleared Oct 13, 1998
DRUG CALIBRATOR II
K982871
Dade Behring, Inc.
Toxicology · 60d
Cleared May 08, 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT
K981403
Beckman Instruments, Inc.
Toxicology · 21d
Cleared Apr 21, 1998
CEDIA DAU MULTI-DRUG CALIBRATORS
K980853
Boehringer Mannheim Corp.
Toxicology · 47d
Cleared Jan 22, 1998
REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE
K974699
Consolidated Technologies, Inc.
Toxicology · 37d
Cleared Jun 25, 1997
EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH)
K971600
Behring Diagnostics, Inc.
Toxicology · 55d
Cleared May 08, 1997
SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUS
K971287
Beckman Instruments, Inc.
Toxicology · 31d
Cleared Sep 16, 1996
DRUG CALIBRATOR II
K962817
Dade Intl., Inc.
Toxicology · 59d
Cleared Sep 10, 1996
CEDIA ANTIBIOTIC TDM MULTI-CALS
K963191
Boehringer Mannheim Corp.
Toxicology · 26d
Cleared May 15, 1996
AED CALIBRATORS
K961273
Diagnostic Reagents, Inc.
Toxicology · 43d
Cleared May 01, 1996
SERUM TOX CALIBRATOR
K961372
Diagnostic Reagents, Inc.
Toxicology · 22d
Cleared Dec 26, 1995
CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGH
K954608
Boehringer Mannheim Corp.
Chemistry · 83d
Cleared Mar 24, 1995
EMIT IIC CALIBRATORS
K935192
Syva Co.
Chemistry · 514d
Cleared Feb 22, 1995
DRUGS OF ABUSE CALIBRATOR
K950139
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 40d
Cleared Dec 13, 1994
DOA - IMMUNOASSAY CUT-OFF CALIBRATOR
K945289
Medi-Tech, Inc.
Toxicology · 43d
Cleared Oct 04, 1994
ROCHE AMMONIA (VARIOUS)
K942048
Roche Diagnostic Systems, Inc.
Chemistry · 159d
Cleared Jul 06, 1994
URINE CALIBRATOR
K940935
Diagnostic Reagents, Inc.
Toxicology · 131d
Cleared Mar 14, 1994
CEDIA DAU NEGATIVE CALIBRATOR
K935793
Microgenics Corp.
Toxicology · 97d
Cleared Mar 14, 1994
CEDIA(R) DAU BAR/BENZ 300,300 INTERMED & HIGH CALIB
K936028
Microgenics Corp.
Toxicology · 87d
Cleared Jan 27, 1994
URINE CALIBRATORS AND CONTROLS MODIFICATION
K935101
Diagnostic Reagents, Inc.
Toxicology · 99d
Cleared Jan 25, 1994
CEDIA DAU 5-DRUG CALIBRATORS
K935792
Microgenics Corp.
Toxicology · 49d
Cleared Jan 25, 1994
CEDIA DAU 4-DRUG CUTOFF CALIBRATOR
K935794
Microgenics Corp.
Toxicology · 49d
Cleared Jan 03, 1994
ABUSCREEN ONLINE NEGATIVE CAL/CONTROL CAL PACK AND MIL CALIBRATION PACK
K935550
Roche Diagnostic Systems, Inc.
Toxicology · 47d
Cleared Aug 03, 1993
ABUSCREEN ONLINE(R) CALIBRATORS
K931124
Roche Diagnostic Systems, Inc.
Toxicology · 152d