K942619 is an FDA 510(k) clearance for the EMIT 2000 DIGOXIN ASSAY/CALIBRATORS. This device is classified as a Enzyme Immunoassay, Digitoxin (Class II - Special Controls, product code LFM).
Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on September 20, 1994, 117 days after receiving the submission on May 26, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3300.
| 510(k) Number | K942619 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 1994 |
| Decision Date | September 20, 1994 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | LFM — Enzyme Immunoassay, Digitoxin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3300 |