K780889 is an FDA 510(k) clearance for the DIGOXIN STANDARDS IN HUMAN SERUM. This device is classified as a Digoxin Control Serum, Ria (Class I - General Controls, product code DMP).
Submitted by Pcl-Ria, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 14, 1978, 75 days after receiving the submission on May 31, 1978.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K780889 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 1978 |
| Decision Date | August 14, 1978 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DMP — Digoxin Control Serum, Ria |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3280 |