K973973 is an FDA 510(k) clearance for the ELECSYS CALLCHECK DIGOXIN. This device is classified as a Digoxin Control Serum, Ria (Class I - General Controls, product code DMP).
Submitted by Boehringer Mannheim Corp. (Pleasanton, US). The FDA issued a Cleared decision on November 4, 1997, 15 days after receiving the submission on October 20, 1997.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K973973 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 1997 |
| Decision Date | November 04, 1997 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DMP — Digoxin Control Serum, Ria |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3280 |