K010080 is an FDA 510(k) clearance for the INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST. This device is classified as a Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep. (Class II - Special Controls, product code DOE).
Submitted by Alfa Scientific Designs, Inc. (Poway, US). The FDA issued a Cleared decision on May 29, 2001, 139 days after receiving the submission on January 10, 2001.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3640.
| 510(k) Number | K010080 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 2001 |
| Decision Date | May 29, 2001 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DOE — Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3640 |