K854572 is an FDA 510(k) clearance for the COATEST PLASMINOGEN. This device is classified as a Plasminogen, Antigen, Antiserum, Control (Class I - General Controls, product code DDX).
Submitted by Kabivitrum, Inc. (Alameda, US). The FDA issued a Cleared decision on February 26, 1986, 104 days after receiving the submission on November 14, 1985.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 866.5715.
| 510(k) Number | K854572 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 1985 |
| Decision Date | February 26, 1986 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | DDX — Plasminogen, Antigen, Antiserum, Control |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.5715 |