K933572 is an FDA 510(k) clearance for the URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125). This device is classified as a Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep. (Class II - Special Controls, product code DOE).
Submitted by Immunalysis Corporation (Glendale, US). The FDA issued a Cleared decision on April 6, 1994, 257 days after receiving the submission on July 23, 1993.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3640.
| 510(k) Number | K933572 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 1993 |
| Decision Date | April 06, 1994 |
| Days to Decision | 257 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | DOE — Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3640 |