K970881 is an FDA 510(k) clearance for the CEDIA DIGOXIN. This device is classified as a Enzyme Immunoassay, Digoxin (Class II - Special Controls, product code KXT).
Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on May 14, 1997, 65 days after receiving the submission on March 10, 1997.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K970881 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 1997 |
| Decision Date | May 14, 1997 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | KXT — Enzyme Immunoassay, Digoxin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |