K914151 is an FDA 510(k) clearance for the IL TEST(TM DIGOXIN. This device is classified as a Enzyme Immunoassay, Digoxin (Class II - Special Controls, product code KXT).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on November 29, 1991, 74 days after receiving the submission on September 16, 1991.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K914151 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 1991 |
| Decision Date | November 29, 1991 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | KXT — Enzyme Immunoassay, Digoxin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |