ClearanceBrief
Panels › Clinical Toxicology › Product code DJR · Class 2

Enzyme Immunoassay, Methadone

Regulation 862.3620

0510(k)s in 12 months (63 all time)
0recalls in 12 months (9 all time)
7recalls that name a 510(k)
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Top companies in DJR

Decided510(k)Device and applicantCode
Nov 9, 1993K934147DUPONT ACA METHADONE (UMETH) SCREEN TEST PACK
E.I. Dupont DE Nemours & Co., Inc.
DJR
Sep 24, 1993K930928ROCHE ABUSCREEN ONLINE FOR METHADONE
Roche Diagnostic Systems, Inc.
DJR
Aug 23, 1993K931780METHADONE METABOLITE EIA ASSAY
Diagnostic Reagents, Inc.
DJR
Apr 24, 1992K920858IL TEST METHADONE
Instrumentation Laboratory CO
DJR
Mar 13, 1992K920751SYVA EMIT II METHADONE ASSAY
Syva Co.
DJR
May 23, 1991K911954REMEDI(TM) DRUG PROFILING SYSTEM, MODIFICATION
Bio-Rad
DJR
Dec 16, 1988K884968TDX METHADONE ASSAY
Abbott Laboratories
DJR
Oct 28, 1987K873899REVISED LABELING FOR SYVA METHADONE ASSAYS
Syva Co.
DJR
Oct 15, 1987K873750LABELING CHANGES COAT-A-COUNT METHADONE IN URINE
Diagnostic Products Corp.
DJR
Mar 19, 1987K870937COAT-A-COUNT METHADONE TKMD1
Diagnostic Products Corp.
DJR
Apr 1, 1985K850953EMIT 700 METHADONE ASSAY
Syva Co.
DJR
Sep 26, 1984K842676EMIT D.A.U. METHADONE ASSAY
Syva Co.
DJR
Mar 19, 1984K840060EMIT ST URINE METHADONE ASSAY
Syva Co.
DJR

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