LAS · Class I · 21 CFR 862.3280

FDA Product Code LAS: Drug Specific Control Materials

Leading manufacturers include Syva Co., Roche Diagnostic Systems, Inc. and E.I. Dupont DE Nemours & Co., Inc..

83
Total
83
Cleared
61d
Avg days
1976
Since

FDA 510(k) Cleared Drug Specific Control Materials Devices (Product Code LAS)

83 devices
1–24 of 83
Cleared Apr 17, 1997
SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS
K971210
Beckman Instruments, Inc.
Toxicology · 15d
Cleared Feb 07, 1995
ROCHE-TDM ONLEIN(TM) CONTROLS
K946119
Roche Diagnostic Systems, Inc.
Toxicology · 54d
Cleared Jan 27, 1994
ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE
K930844
Roche Diagnostic Systems, Inc.
Toxicology · 343d
Cleared Nov 09, 1993
DUPONT ACA URINE METHADONE CONTROL
K934145
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 76d
Cleared Jan 28, 1992
ABUSCREEN ONLINE CANNABINOIDS POSITIVE CONTROL
K915516
Roche Diagnostic Systems, Inc.
Toxicology · 50d
Cleared Aug 26, 1991
ABUSCREEN(R) ONLINE(TM) CONTROLS
K913336
Roche Diagnostic Systems, Inc.
Toxicology · 34d
Cleared Aug 12, 1991
ABUSCREEN(R) ONTRAK(R) POSITIVE REF CONT BENZODIAZ
K913107
Roche Diagnostic Systems, Inc.
Toxicology · 31d
Cleared Apr 03, 1991
LYPHOCHEK BENZO/TCA CONTROL SERUM, LEVELS 1 AND 2
K910829
Bio-Rad
Toxicology · 35d
Cleared Mar 11, 1991
ABUSCREEN(R) ONLINE CONTROLS
K910689
Roche Diagnostic Systems, Inc.
Toxicology · 20d
Cleared Aug 28, 1989
ABUSCREEN POSITIVE REFERENCE CONTROLS
K894464
Roche Diagnostic Systems, Inc.
Toxicology · 39d
Cleared Aug 21, 1989
ABUSCREEN TRI-LEVEL REFERENCE CONTROLS
K894463
Roche Diagnostic Systems, Inc.
Toxicology · 32d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS. REF. CONTROL FOR BARBITUATES
K893855
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS. REF. CONTROL FOR MORPHINE
K893856
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS. REF. CONTROL FOR AMPHETAMINE
K893857
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS. REFERENCE CONTROL FOR THC
K893858
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS. REF. CONTROL FOR COCAINE
K893859
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS.REF.CONTROL FOR PHENCYCLIDINE
K893860
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Apr 21, 1989
LIQUICHEK(R) SERUM ALCOHOL CONTROL
K892004
Bio-Rad
Chemistry · 24d
Cleared Nov 29, 1988
DU PONT DIMENSION PSEUDOCHOLINESTERASE VERIFIER
K883891
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 76d
Cleared Oct 05, 1984
EMIT 700 CANNABINOID CONTROL SET
K843419
Syva Co.
Toxicology · 35d
Cleared May 11, 1984
ACA TRICYCLIC ANTIDEPRESSANTS SCREEN
K841533
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 25d
Cleared Jul 19, 1983
EMIT SERUM TRICYCLIC ANTIDEPRESS. CONTRO
K831979
Syva Co.
Toxicology · 29d
Cleared Jun 16, 1983
EMIT QST TOBRAMYCIN CONTROL
K831417
Syva Co.
Toxicology · 44d
Cleared Jan 28, 1983
ADVANCE EMIT-CAD DISOPYRAMIDE CONTROL
K830049
Syva Co.
Chemistry · 18d

About Product Code LAS - Regulatory Context