K895484 is an FDA 510(k) clearance for the STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO.. This device is classified as a Enzyme Immunoassay, Gentamicin (Class II - Special Controls, product code LCD).
Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on October 4, 1989, 23 days after receiving the submission on September 11, 1989.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3450.
| 510(k) Number | K895484 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 1989 |
| Decision Date | October 04, 1989 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LCD — Enzyme Immunoassay, Gentamicin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3450 |