K780949 is an FDA 510(k) clearance for the BIO-MONITOR AMIKACIN. This device is classified as a Amikacin Serum Assay (Class II - Special Controls, product code KLP).
Submitted by Monitor Science Corp. (Mchenry, US). The FDA issued a Cleared decision on August 14, 1978, 66 days after receiving the submission on June 9, 1978.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3035.
| 510(k) Number | K780949 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 1978 |
| Decision Date | August 14, 1978 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | KLP — Amikacin Serum Assay |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3035 |