Panels › Clinical Toxicology › Product code DKZ · Class 2
Enzyme Immunoassay, Amphetamine
Regulation 862.3100
0510(k)s in 12 months (225 all time)
0recalls in 12 months (24 all time)
20recalls that name a 510(k)
Top companies in DKZ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 25, 1989 | K895210 | LABELING SUBMITTAL, ADX AMPHETAMINE/METHAMPHETA.II Abbott Laboratories | DKZ |
| Aug 25, 1989 | K890692 | ADX AMPHETAMINE/METHAMPHEAMINE Abbott Laboratories | DKZ |
| Aug 15, 1989 | K894465 | ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE Roche Diagnostic Systems, Inc. | DKZ |
| Aug 11, 1989 | K894404 | EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE Syva Co. | DKZ |
| Mar 10, 1989 | K890886 | ABUSCREEN FP FOR AMPHETAMINE Roche Diagnostic Systems, Inc. | DKZ |
| Oct 20, 1988 | K883707 | TDX AMPHETAMINE/METHAMPHETAMINE II Abbott Laboratories | DKZ |
| Oct 11, 1988 | K884022 | EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE Syva Co. | DKZ |
| Aug 2, 1988 | K882589 | EMIT HVA AMPHETAMINE ASSAY Syva Co. | DKZ |
| Apr 21, 1988 | K874770 | TDX (R) AMPHETAMINE CLASS Abbott Laboratories | DKZ |
| Mar 1, 1988 | K880013 | REVISED LABELING FOR ADX AMPHETAMINE/METHAMPHETA. Abbott Laboratories | DKZ |
| Feb 16, 1988 | K874836 | ABUSCREEN(R) EIA AMPHETAMINE Roche Diagnostic Systems, Inc. | DKZ |
| Nov 23, 1987 | K874486 | REVISED LABELING FOR TDX AMPHETAMINE/METHAMPHETA. Abbott Laboratories | DKZ |
| Nov 13, 1987 | K874274 | REVISED LABELING FOR AMPHETAMINE TEST KIT Roche Diagnostic Systems, Inc. | DKZ |
| Nov 13, 1987 | K874273 | REVISED LABELING FOR AMPHETAMINE TEST KIT Roche Diagnostic Systems, Inc. | DKZ |
| Oct 29, 1987 | K874080 | REVISED LABELING FOR SYVA AMPHETAMINE ASSAY Syva Co. | DKZ |
| Oct 15, 1987 | K873755 | LABELING CHANGE AMPHETAMINE DOUBLE ANTIBODY Diagnostic Products Corp. | DKZ |
| Oct 2, 1987 | K873622 | ACA DU PONT URINE AMPHETAMINES (U AMP) SCREEN METH E.I. Dupont DE Nemours & Co., Inc. | DKZ |
| Jun 5, 1987 | K871696 | DOUBLE ANTIBODY AMPHETAMINE KAPD1 AND KAPD5 Diagnostic Products Corp. | DKZ |
| Oct 28, 1985 | K853879 | TDX AMPHETAMINE METHAMPHETAMINE Abbott Laboratories | DKZ |
| Sep 26, 1984 | K842674 | EMIT D.A.U. AMPHETAMINE ASSAY Syva Co. | DKZ |
| Sep 20, 1984 | K843458 | EMIT 700 AMPHETAMINE ASSAY NEW PRODUCT Syva Co. | DKZ |
| Jan 26, 1984 | K833579 | MODIF. OF EMIT URINE AMPHETAMINE Syva Co. | DKZ |
| Nov 12, 1980 | K802623 | EMIT-STM AMPHETAMINE ASSAY Syva Co. | DKZ |
| Nov 19, 1976 | K760936 | EMIT AMPHETAMINE CONFIRMATION REAGENT Syva Co. | DKZ |
| Aug 3, 1976 | K760196 | ASSAY, AMPHET. NDC#11711-0127-1 COULTER Coulter Electronics, Inc. | DKZ |
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