K011011 is an FDA 510(k) clearance for the LIVESURE MORPHINE SCREEN 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 Pan Probe Biotech, Inc. (San Diego, US). The FDA issued a Cleared decision on April 13, 2001, 9 days after receiving the submission on April 4, 2001.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3640.
| 510(k) Number | K011011 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2001 |
| Decision Date | April 13, 2001 |
| Days to Decision | 9 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 |