The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Digitoxin Fpia Calibrator Set.
| Device ID | K915464 |
| 510k Number | K915464 |
| Device Name: | DIGITOXIN FPIA CALIBRATOR SET |
| Classification | Calibrators, Drug Specific |
| 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 | DLJ |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-02 |
| Decision Date | 1992-01-15 |