K850410 is an FDA 510(k) clearance for the GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY. This device is classified as a Plasminogen, Antigen, Antiserum, Control (Class I - General Controls, product code DDX).
Submitted by Warner-Lambert Co. (Morris Plains, US). The FDA issued a Cleared decision on May 8, 1985, 93 days after receiving the submission on February 4, 1985.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5715.
| 510(k) Number | K850410 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 1985 |
| Decision Date | May 08, 1985 |
| Days to Decision | 93 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 |