K832591 is an FDA 510(k) clearance for the DIACROM *PLG. This device is classified as a Plasminogen, Antigen, Antiserum, Control (Class I - General Controls, product code DDX).
Submitted by Wellcome Diagnostics (Mchenry, US). The FDA issued a Cleared decision on November 21, 1983, 111 days after receiving the submission on August 2, 1983.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5715.
| 510(k) Number | K832591 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 1983 |
| Decision Date | November 21, 1983 |
| Days to Decision | 111 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 |