K951631 is an FDA 510(k) clearance for the DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS. This device is classified as a Enzyme Immunoassay, Digitoxin (Class II - Special Controls, product code LFM).
Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on June 9, 1995, 63 days after receiving the submission on April 7, 1995.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3300.
| 510(k) Number | K951631 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 1995 |
| Decision Date | June 09, 1995 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LFM — Enzyme Immunoassay, Digitoxin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3300 |