The following data is part of a premarket notification filed by E. R. Squibb & Sons, Inc. with the FDA for Diagoxin Squibb Radioimmunoassay Kit.
| Device ID | K810966 |
| 510k Number | K810966 |
| Device Name: | DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT |
| Classification | Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Second Antibody Sep. |
| Applicant | E. R. SQUIBB & SONS, INC. 40 W 57TH ST. New York, NY 10019 |
| Product Code | DNL |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-08 |
| Decision Date | 1981-04-21 |