The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Digoxin Fpia Reagent Set And Calibrator Set.
| Device ID | K940569 |
| 510k Number | K940569 |
| Device Name: | DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET |
| Classification | Enzyme Immunoassay, Digoxin |
| Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Contact | Barry D Robins |
| Correspondent | Barry D Robins SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Product Code | KXT |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-08 |
| Decision Date | 1994-07-13 |