K812625 is an FDA 510(k) clearance for the ACA PLASMINOGEN TEST PACK. This device is classified as a Plasminogen, Antigen, Antiserum, Control (Class I - General Controls, product code DDX).
Submitted by E.I. Dupont DE Nemours & Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 29, 1981, 14 days after receiving the submission on September 15, 1981.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5715.
| 510(k) Number | K812625 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 1981 |
| Decision Date | September 29, 1981 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DDX — Plasminogen, Antigen, Antiserum, Control |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.5715 |