K991597 is an FDA 510(k) clearance for the COBAS INTEGRA AMIKACIN MAB. This device is classified as a Fluorescence Polarization Immunoassay, Amibacin (Class II - Special Controls, product code LGJ).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on July 22, 1999, 73 days after receiving the submission on May 10, 1999.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3035.
| 510(k) Number | K991597 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 1999 |
| Decision Date | July 22, 1999 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LGJ — Fluorescence Polarization Immunoassay, Amibacin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3035 |