Panels › Clinical Toxicology › Product code DOE · Class 2
Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
Regulation 862.3640
0510(k)s in 12 months (12 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in DOE
| Company | 510(k)s | Recalls |
|---|---|---|
| Roche Diagnostic Systems, Inc. | 3 | 0 |
| Alfa Scientific Designs, Inc. | 2 | 0 |
| Hoffmann-La Roche, Inc. | 2 | 0 |
| Branan Medical Corporation | 1 | 0 |
| Diagnostic Products Corp. | 1 | 0 |
| Icn Micromedic Systems | 1 | 0 |
| Immunalysis Corporation | 1 | 0 |
| Pan Probe Biotech, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 29, 2001 | K010080 | INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST Alfa Scientific Designs, Inc. | DOE |
| May 29, 2001 | K010079 | INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST Alfa Scientific Designs, Inc. | DOE |
| Apr 13, 2001 | K011011 | LIVESURE MORPHINE SCREEN TEST Pan Probe Biotech, Inc. | DOE |
| Nov 22, 2000 | K002418 | BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D Branan Medical Corporation | DOE |
| Jun 1, 1995 | K951319 | ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATION Roche Diagnostic Systems, Inc. | DOE |
| Aug 9, 1994 | K935055 | ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF) Roche Diagnostic Systems, Inc. | DOE |
| Apr 6, 1994 | K933572 | URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) Immunalysis Corporation | DOE |
| Jun 24, 1988 | K881102 | MICROMEDIC MORPHINE RIA KIT Icn Micromedic Systems | DOE |
| Mar 19, 1987 | K863913 | THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT Diagnostic Products Corp. | DOE |
| Mar 16, 1987 | K864168 | MORPHINE ROCHE (R) EIA TEST Roche Diagnostic Systems, Inc. | DOE |
| Mar 24, 1983 | K830462 | ABUSCREEN RADIOUMMUNOASSAY--URINE Hoffmann-La Roche, Inc. | DOE |
| Mar 24, 1983 | K830460 | ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE Hoffmann-La Roche, Inc. | DOE |
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