The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Digitoxin Fpia Reagent Set.
| Device ID | K915465 |
| 510k Number | K915465 |
| Device Name: | DIGITOXIN FPIA REAGENT SET |
| Classification | Enzyme Immunoassay, Digitoxin |
| 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 | LFM |
| CFR Regulation Number | 862.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-02 |
| Decision Date | 1992-01-27 |