The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Elecsys Digoxin.
| Device ID | K973112 |
| 510k Number | K973112 |
| Device Name: | ELECSYS DIGOXIN |
| Classification | Enzyme Immunoassay, Digoxin |
| Applicant | BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. Concord, CA 94524 |
| Contact | Yvette R Lloyd |
| Correspondent | Yvette R 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 | 1997-08-20 |
| Decision Date | 1997-10-10 |
| Summary: | summary |