K010984 is an FDA 510(k) clearance for the EMIT 2000 GENTAMICIN PLUS ASSAY. This device is classified as a Enzyme Immunoassay, Gentamicin (Class II - Special Controls, product code LCD).
Submitted by Syva Co., Dade Behring, Inc. (San Jose, US). The FDA issued a Cleared decision on April 20, 2001, 18 days after receiving the submission on April 2, 2001.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3450.
| 510(k) Number | K010984 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 2001 |
| Decision Date | April 20, 2001 |
| Days to Decision | 18 days |
| Submission Type | Special |
| 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 |