K901216 is an FDA 510(k) clearance for the ENZYMUN TEST(R) DIGOXIN. This device is classified as a Enzyme Immunoassay, Digoxin (Class II - Special Controls, product code KXT).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on May 31, 1990, 78 days after receiving the submission on March 14, 1990.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K901216 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 1990 |
| Decision Date | May 31, 1990 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | KXT — Enzyme Immunoassay, Digoxin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |