K904990 is an FDA 510(k) clearance for the EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS. This device is classified as a Enzyme Immunoassay, Quinidine (Class II - Special Controls, product code LBZ).
Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on February 4, 1991, 90 days after receiving the submission on November 6, 1990.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K904990 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 1990 |
| Decision Date | February 04, 1991 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LBZ — Enzyme Immunoassay, Quinidine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |