The following data is part of a premarket notification filed by Biotope, Inc. with the FDA for Eclipse Ica Digoxin.
| Device ID | K905719 |
| 510k Number | K905719 |
| Device Name: | ECLIPSE ICA DIGOXIN |
| Classification | Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Coated Tube Sep. |
| Applicant | BIOTOPE, INC. 12277 134TH CT., N.E. Redmond, WA 98052 |
| Contact | Lynn Shanta |
| Correspondent | Lynn Shanta BIOTOPE, INC. 12277 134TH CT., N.E. Redmond, WA 98052 |
| Product Code | DPO |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-21 |
| Decision Date | 1991-01-17 |