K791551 is an FDA 510(k) clearance for the HI-M-TEST MORPHINE. This device is classified as a Hemagglutination Inhibition, Morphine (Class II - Special Controls, product code DLR).
Submitted by Technam, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 17, 1979, 64 days after receiving the submission on August 14, 1979.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3640.
| 510(k) Number | K791551 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 14, 1979 |
| Decision Date | October 17, 1979 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DLR — Hemagglutination Inhibition, Morphine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3640 |