K903192 is an FDA 510(k) clearance for the IL TOBRAMYCIN ASSAY. This device is classified as a Radioimmunoassay, Tobramycin (Class II - Special Controls, product code KLB).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on August 22, 1990, 34 days after receiving the submission on July 19, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3900.
| 510(k) Number | K903192 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 1990 |
| Decision Date | August 22, 1990 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | KLB — Radioimmunoassay, Tobramycin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3900 |