K082953 is an FDA 510(k) clearance for the ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01. This device is classified as a Enzyme Immunoassay, Digoxin (Class II - Special Controls, product code KXT).
Submitted by Biokit, S.A. (Barcelona, ES). The FDA issued a Cleared decision on December 22, 2008, 80 days after receiving the submission on October 3, 2008.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K082953 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2008 |
| Decision Date | December 22, 2008 |
| Days to Decision | 80 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 |