K990251 is an FDA 510(k) clearance for the DGTX FLEX REAGENT CARTRIDGE, MODEL DF36. 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 March 31, 1999, 63 days after receiving the submission on January 27, 1999.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3300.
| 510(k) Number | K990251 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 1999 |
| Decision Date | March 31, 1999 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| 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 |