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 Microgenics Corp..

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 Oct 30, 2006
QUANTIMETRIX NICOSURE COTININE URINE CONTROL
K062942
Quantimetrix Corp.
Toxicology · 32d
Cleared Jun 06, 2005
MAS IMMUNOSUPPRESSANT CONTROLS
K051074
Microgenics Corp.
Toxicology · 40d
Cleared May 27, 2004
DRI OXYCODONE ASSAY
K040411
Microgenics Corp.
Toxicology · 99d
Cleared Oct 17, 2003
MICROGENICS CYCLOSPORINE CONTROL KIT
K032842
Microgenics Corp.
Chemistry · 36d
Cleared Mar 31, 2003
CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5
K030616
Microgenics Corp.
Toxicology · 33d
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 Aug 24, 1994
MICROGENICS THC CONTROL SETS
K943048
Microgenics Corp.
Toxicology · 58d
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 Jul 16, 1992
SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR)
K921939
Heraeus Kulzer, Inc.
Toxicology · 83d
Cleared Apr 17, 1992
CANNABINOID URINE CONTROLS
K921141
Diagnostic Reagents, Inc.
Toxicology · 38d
Cleared Jan 28, 1992
ABUSCREEN ONLINE CANNABINOIDS POSITIVE CONTROL
K915516
Roche Diagnostic Systems, Inc.
Toxicology · 50d
Cleared Sep 25, 1991
ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III
K913677
Analytical Control Systems, Inc.
Toxicology · 37d
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

About Product Code LAS - Regulatory Context