K864212 is an FDA 510(k) clearance for the IL TEST 97573-15, PLASMINOGEN ASSAY. This device is classified as a Plasminogen, Antigen, Antiserum, Control (Class I - General Controls, product code DDX).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on December 4, 1986, 37 days after receiving the submission on October 28, 1986.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 866.5715.
| 510(k) Number | K864212 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 1986 |
| Decision Date | December 04, 1986 |
| Days to Decision | 37 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 |