DOE — Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep. Class II
FDA product code DOE covers "Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.", a Class II medical device regulated under 21 CFR 862.3640. Submissions are reviewed by the Clinical Toxicology panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DOE
- Device Class
- Class II
- Regulation Number
- 862.3640
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K010080 | alfa scientific designs | INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST | May 29, 2001 |
| K010079 | alfa scientific designs | INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST | May 29, 2001 |
| K011011 | pan probe biotech | LIVESURE MORPHINE SCREEN TEST | April 13, 2001 |
| K002418 | branan medical corporation | BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AN | November 22, 2000 |
| K951319 | roche diagnostic systems | ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 | June 1, 1995 |
| K935055 | roche diagnostic systems | ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF) | August 9, 1994 |
| K933572 | immunalysis corporation | URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) | April 6, 1994 |
| K881102 | icn micromedic systems | MICROMEDIC MORPHINE RIA KIT | June 24, 1988 |
| K863913 | diagnostic products | THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT | March 19, 1987 |
| K864168 | roche diagnostic systems | MORPHINE ROCHE (R) EIA TEST | March 16, 1987 |
| K830460 | hoffmann-la roche | ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE | March 24, 1983 |
| K830462 | hoffmann-la roche | ABUSCREEN RADIOUMMUNOASSAY--URINE | March 24, 1983 |