The following data is part of a premarket notification filed by Syva Co. with the FDA for Digoxin Test System, Kxt Tx.
| Device ID | K931123 |
| 510k Number | K931123 |
| Device Name: | DIGOXIN TEST SYSTEM, KXT TX |
| Classification | Enzyme Immunoassay, Digoxin |
| Applicant | SYVA CO. P.O. BOX 49013 San Jose, CA 95161 -9013 |
| Contact | Paul L Rogers |
| Correspondent | Paul L Rogers SYVA CO. 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 | 1993-03-04 |
| Decision Date | 1993-08-05 |