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 |
|---|---|---|---|
| May 8, 2002 | K020313 | ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD; ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE Acon Laboratories Co. | DKZ |
| Jan 10, 2002 | K012745 | TRIAGE TOX DRUG SCREEN, CATALOG #94000 Biosite Incorporated | DKZ |
| Nov 30, 2001 | K012484 | AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE Ameditech, Inc. | DKZ |
| Nov 5, 2001 | K012396 | ONTRAK TESTCARD 9 Roche Diagnostics Corp. | DKZ |
| Oct 25, 2001 | K011952 | DRUGS OF ABUSE MULTI-TEST STRIP Microdiagnostics, Inc. | DKZ |
| Aug 27, 2001 | K012110 | DRI ECSTASY ENZYME IMMUNOASSAY Microgenics Corp. | DKZ |
| Aug 3, 2001 | K012257 | EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229 Syva Co. | DKZ |
| Jul 31, 2001 | K011673 | ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE ACON Laboratories, Inc. | DKZ |
| Jul 25, 2001 | K012159 | RAPID DRUG SCREEN American Bio Medica Corp. | DKZ |
| Jul 17, 2001 | K011499 | VISUALINE AMPHETAMINE DIPSTRIP ASSAY Sun Biomedical Laboratories, Inc. | DKZ |
| Jun 8, 2001 | K011609 | LIVESURE AMPHETAMINE SCREEN TEST Pan Probe Biotech, Inc. | DKZ |
| May 17, 2001 | K010177 | VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY Sun Biomedical Laboratories, Inc. | DKZ |
| Apr 20, 2001 | K003809 | RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS Rapid Diagnostics, Inc. | DKZ |
| Apr 5, 2001 | K010564 | VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO; PROFILE -II 7 THC/COC/OPI/AMP/PCP/BAR/BZO Medtox Diagnostics, Inc. | DKZ |
| Mar 30, 2001 | K010645 | AT HOME DRUG TEST, MODEL 9063 T Phamatech | DKZ |
| Mar 8, 2001 | K004034 | MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12 Branan Medical Corp. | DKZ |
| Feb 28, 2001 | K003865 | COBAS INTEGRA AMPHETAMINES Roche Diagnostics Corp. | DKZ |
| Nov 22, 2000 | K002266 | BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST Branan Medical Corporation | DKZ |
| Nov 16, 2000 | K002447 | MODIFICATION TO RAPID DRUG SCREEN 9-PANEL American Bio Medica Corp. | DKZ |
| Aug 7, 2000 | K994395 | INSTANT-VIEW AMPHETAMINE URINE CASSETTE TEST Alfa Scientific Designs, Inc. | DKZ |
| Aug 4, 2000 | K994399 | INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST Alfa Scientific Designs, Inc. | DKZ |
| Jul 12, 2000 | K001421 | ONTRAK TESTCUP 501, MODEL 3016633 Roche Diagnostics Corp. | DKZ |
| Jun 29, 2000 | K001417 | ONTRAK TESTCUP 502, MODEL 3016641 Roche Diagnostics Corp. | DKZ |
| May 26, 2000 | K001397 | QUICKSCREEN PRO DRUG CUP, MODEL 9195X Phamatech | DKZ |
| May 17, 2000 | K001225 | ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U. Princeton BioMeditech Corp. | DKZ |
| May 5, 2000 | K000606 | SYNCHRON SYSTEMS AMPHETAMINE REAGENT Beckman Coulter, Inc. | DKZ |
| May 2, 2000 | K994380 | CEDIA DAU AMPHASSURE ASSAY Microgenics Corp. | DKZ |
| Apr 18, 2000 | K000400 | SCREENERS AMPHETAMINE TEST, DRUGSCREEN DIP AMPHETAMINE TEST Drug Detection Devices, Ltd. | DKZ |
| Apr 14, 2000 | K000460 | URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A Dade Behring, Inc. | DKZ |
| Apr 3, 2000 | K992918 | STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I OraSure Technologies, Inc. | DKZ |
| Jan 27, 2000 | K992632 | IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5 Diagnostic Products Corp. | DKZ |
| Dec 30, 1999 | K994237 | AT HOME DRUG TEST, MODEL 9063 Phamatech | DKZ |
| Jul 15, 1999 | K990681 | DBSET MULTIDRUG SCREEN TEST KIT Ameritek, Inc. | DKZ |
| Jun 30, 1999 | K992033 | MODIFICATION TO 'RAPID DRUG SCREEN' 9-PANEL American Bio Medica Corp. | DKZ |
| Jun 24, 1999 | K990325 | QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE Syntron Bioresearch, Inc. | DKZ |
| Apr 15, 1999 | K990399 | ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8 Roche Diagnostics Corp. | DKZ |
| Apr 13, 1999 | K990418 | ONTRAK TESTCUP-ER M2K Roche Diagnostics Corp. | DKZ |
| Feb 26, 1999 | K984525 | RAPID DRUG SCREEN 5-PANEL WITH METHAMPHETAMINE TEST American Bio Medica Corp. | DKZ |
| Feb 23, 1999 | K990337 | ONTRAK TESTCUP-5 M2K Roche Diagnostics Corp. | DKZ |
| Dec 31, 1998 | K983770 | 'RAPID DRUG SCREEN' 9-PANEL American Bio Medica Corp. | DKZ |
| Dec 11, 1998 | K983699 | MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES Roche Diagnostic Systems, Inc. | DKZ |
| Aug 27, 1998 | K981705 | 'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME American Bio Medica Corp. | DKZ |
| Aug 6, 1998 | K981504 | DBEST AMPHETAMINES TEST KIT Ameritek, Inc. | DKZ |
| Jun 16, 1998 | K981197 | ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST Tcpi, Inc. | DKZ |
| Apr 1, 1998 | K980865 | QUICKSCREEN PRO MULTI DRUG SCREENING TEST , MODEL 9140-9147, 9061,9066, 9071, 9076, 9081 AND 9131 Phamatech | DKZ |
| Mar 20, 1998 | K974611 | MICRO-STRIP FOR AMPHETAMINE METABOLITES Microdiagnostics, Inc. | DKZ |
| Jan 28, 1998 | K972989 | STC METHAMPHETAMINE MICRO-PLATE EIA OraSure Technologies, Inc. | DKZ |
| Dec 3, 1997 | K973784 | TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS Biosite Incorporated | DKZ |
| Nov 6, 1997 | K973726 | FINGERPRINT DRUG SCREENING DEVICE Applied Technology Ventures, LLC | DKZ |
| Oct 9, 1997 | K973075 | ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ON Roche Diagnostic Systems, Inc. | DKZ |
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