K962099 is an FDA 510(k) clearance for the CEDIA PROCAINAMIDE ASSAY. This device is classified as a Enzyme Immunoassay, Procainamide (Class II - Special Controls, product code LAR).
Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on August 27, 1996, 90 days after receiving the submission on May 29, 1996.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K962099 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 1996 |
| Decision Date | August 27, 1996 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LAR — Enzyme Immunoassay, Procainamide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |