The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Cedia Digoxin.
| Device ID | K970881 |
| 510k Number | K970881 |
| Device Name: | CEDIA DIGOXIN |
| Classification | Enzyme Immunoassay, Digoxin |
| Applicant | BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. Concord, CA 94524 |
| Contact | Yvette Lloyd |
| Correspondent | Yvette Lloyd BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. Concord, CA 94524 |
| Product Code | KXT |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-10 |
| Decision Date | 1997-05-14 |
| Summary: | summary |