K012112 is an FDA 510(k) clearance for the RANDOX DIGITOXIN. This device is classified as a Enzyme Immunoassay, Digitoxin (Class II - Special Controls, product code LFM).
Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on January 11, 2002, 189 days after receiving the submission on July 6, 2001.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3300.
| 510(k) Number | K012112 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2001 |
| Decision Date | January 11, 2002 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | LFM — Enzyme Immunoassay, Digitoxin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3300 |