K911940 is an FDA 510(k) clearance for the OPUS(R) TOBRAMYCIN. This device is classified as a Fluorescent Immunoassay, Tobramycin (Class II - Special Controls, product code LCR).
Submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on July 1, 1991, 61 days after receiving the submission on May 1, 1991.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3900.
| 510(k) Number | K911940 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 1991 |
| Decision Date | July 01, 1991 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | LCR — Fluorescent Immunoassay, Tobramycin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3900 |