K760074 is an FDA 510(k) clearance for the KIT, MORPHINE (TOXI-PAK IMMUNO HI). This device is classified as a Hemagglutination Inhibition, Morphine (Class II - Special Controls, product code DLR).
Submitted by J.T. Baker Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on July 20, 1976, 32 days after receiving the submission on June 18, 1976.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3640.
| 510(k) Number | K760074 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 18, 1976 |
| Decision Date | July 20, 1976 |
| Days to Decision | 32 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 |