The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Digoxin Fpia Calibrators.
| Device ID | K872328 |
| 510k Number | K872328 |
| Device Name: | DIGOXIN FPIA CALIBRATORS |
| Classification | Calibrators, Drug Specific |
| Applicant | SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Contact | Dennis Murray |
| Correspondent | Dennis Murray SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Product Code | DLJ |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-17 |
| Decision Date | 1987-07-07 |