K772038 is an FDA 510(k) clearance for the KANAMYCIN RIA. This device is classified as a Radioimmunoassay, Kanamycin (Class II - Special Controls, product code KJI).
Submitted by Monitor Science Corp. (Mchenry, US). The FDA issued a Cleared decision on January 12, 1978, 76 days after receiving the submission on October 28, 1977.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.3520.
| 510(k) Number | K772038 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 1977 |
| Decision Date | January 12, 1978 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | KJI — Radioimmunoassay, Kanamycin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3520 |