The following data is part of a premarket notification filed by Syva Co. with the FDA for Emit 2000 Digoxin Assay/calibrators Modification.
| Device ID | K934135 |
| 510k Number | K934135 |
| Device Name: | EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION |
| Classification | Enzyme Immunoassay, Digoxin |
| Applicant | SYVA CO. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 -9013 |
| Contact | Paul L Rogers Jr. |
| Correspondent | Paul L Rogers Jr. SYVA CO. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 -9013 |
| Product Code | KXT |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-25 |
| Decision Date | 1994-04-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768000973 | K934135 | 000 |