The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Elecsys Callcheck Digoxin.
| Device ID | K973973 |
| 510k Number | K973973 |
| Device Name: | ELECSYS CALLCHECK DIGOXIN |
| Classification | Digoxin Control Serum, Ria |
| Applicant | BOEHRINGER MANNHEIM CORP. 4300 HACIENDA DR. Pleasanton, CA 94588 -2722 |
| Contact | Jody J Savage |
| Correspondent | Jody J Savage BOEHRINGER MANNHEIM CORP. 4300 HACIENDA DR. Pleasanton, CA 94588 -2722 |
| Product Code | DMP |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-20 |
| Decision Date | 1997-11-04 |
| Summary: | summary |