K894517 is an FDA 510(k) clearance for the FPR AMIKACIN KIT. This device is classified as a Radioimmunoassay, Amikacin (Class II - Special Controls, product code KLQ).
Submitted by Colony Laboratories, Inc. (Washington, US). The FDA issued a Cleared decision on September 28, 1989, 70 days after receiving the submission on July 20, 1989.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3035.
| 510(k) Number | K894517 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 1989 |
| Decision Date | September 28, 1989 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | KLQ — Radioimmunoassay, Amikacin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3035 |