K011605 is an FDA 510(k) clearance for the EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229. This device is classified as a Enzyme Immunoassay, Quinidine (Class II - Special Controls, product code LBZ).
Submitted by Syva Co., Dade Behring, Inc. (San Jose, US). The FDA issued a Cleared decision on June 12, 2001, 19 days after receiving the submission on May 24, 2001.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K011605 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 2001 |
| Decision Date | June 12, 2001 |
| Days to Decision | 19 days |
| Submission Type | Special |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LBZ — Enzyme Immunoassay, Quinidine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |