K790899 is an FDA 510(k) clearance for the BACTEC. This device is classified as a Amikacin Serum Assay (Class II - Special Controls, product code KLP).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on May 23, 1979, 14 days after receiving the submission on May 9, 1979.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3035.
| 510(k) Number | K790899 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 1979 |
| Decision Date | May 23, 1979 |
| Days to Decision | 14 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 |