K872175 is an FDA 510(k) clearance for the TDXR FLECAINIDE. This device is classified as a Enzyme Immunoassay, Quinidine (Class II - Special Controls, product code LBZ).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 13, 1987, 66 days after receiving the submission on June 8, 1987.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K872175 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 1987 |
| Decision Date | August 13, 1987 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | LBZ — Enzyme Immunoassay, Quinidine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |