K010812 is an FDA 510(k) clearance for the EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229. This device is classified as a Enzyme Immunoassay, Procainamide (Class II - Special Controls, product code LAR).
Submitted by Syva Co., Dade Behring, Inc. (San Jose, US). The FDA issued a Cleared decision on April 13, 2001, 25 days after receiving the submission on March 19, 2001.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K010812 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 2001 |
| Decision Date | April 13, 2001 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LAR — Enzyme Immunoassay, Procainamide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |