K020704 is an FDA 510(k) clearance for the ROCHE ONLINE GENTAMICIN. This device is classified as a Enzyme Immunoassay, Gentamicin (Class II - Special Controls, product code LCD).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on July 12, 2002, 130 days after receiving the submission on March 4, 2002.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3450.
| 510(k) Number | K020704 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2002 |
| Decision Date | July 12, 2002 |
| Days to Decision | 130 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LCD — Enzyme Immunoassay, Gentamicin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3450 |