K882294 is an FDA 510(k) clearance for the EMIT CONVENIENCE PACK: TOBRAMYCIN ASSAY. This device is classified as a Radioimmunoassay, Tobramycin (Class II - Special Controls, product code KLB).
Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on July 1, 1988, 29 days after receiving the submission on June 2, 1988.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3900.
| 510(k) Number | K882294 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 1988 |
| Decision Date | July 01, 1988 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | KLB — Radioimmunoassay, Tobramycin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3900 |