The following data is part of a premarket notification filed by Syva Co. with the FDA for Emit 2000 Digoxin Assay/calibrators.
| Device ID | K942619 |
| 510k Number | K942619 |
| Device Name: | EMIT 2000 DIGOXIN ASSAY/CALIBRATORS |
| Classification | Enzyme Immunoassay, Digitoxin |
| Applicant | SYVA CO. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 -9013 |
| Contact | Paul J Rogers Jr. |
| Correspondent | Paul J Rogers Jr. SYVA CO. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 -9013 |
| Product Code | LFM |
| CFR Regulation Number | 862.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-26 |
| Decision Date | 1994-09-20 |