The following data is part of a premarket notification filed by Ventrex Laboratories, Inc. with the FDA for Ria Test Kit, Centria Digoxin.
| Device ID | K790540 |
| 510k Number | K790540 |
| Device Name: | RIA TEST KIT, CENTRIA DIGOXIN |
| Classification | Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Charcoal Sep. |
| Applicant | VENTREX LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DPB |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-03-20 |
| Decision Date | 1979-04-23 |