K062024 is an FDA 510(k) clearance for the DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE. This device is classified as a Enzyme Immunoassay, Digitoxin (Class II - Special Controls, product code LFM).
Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on July 28, 2006, 10 days after receiving the submission on July 18, 2006.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3300.
| 510(k) Number | K062024 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2006 |
| Decision Date | July 28, 2006 |
| Days to Decision | 10 days |
| Submission Type | Special |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LFM — Enzyme Immunoassay, Digitoxin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3300 |