K011920 is an FDA 510(k) clearance for the EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229. This device is classified as a Enzyme Immunoassay, Digoxin (Class II - Special Controls, product code KXT).
Submitted by Syva Co., Dade Behring, Inc. (Cupertino, US). The FDA issued a Cleared decision on July 2, 2001, 12 days after receiving the submission on June 20, 2001.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K011920 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 2001 |
| Decision Date | July 02, 2001 |
| Days to Decision | 12 days |
| Submission Type | Special |
| 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 |