K874223 is an FDA 510(k) clearance for the EMIT 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 November 13, 1987, 28 days after receiving the submission on October 16, 1987.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3900.
| 510(k) Number | K874223 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 1987 |
| Decision Date | November 13, 1987 |
| Days to Decision | 28 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 |