K873426 is an FDA 510(k) clearance for the EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645. This device is classified as a Amikacin Serum Assay (Class II - Special Controls, product code KLP).
Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on October 29, 1987, 65 days after receiving the submission on August 25, 1987.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3035.
| 510(k) Number | K873426 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 1987 |
| Decision Date | October 29, 1987 |
| Days to Decision | 65 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 |