K864211 is an FDA 510(k) clearance for the IL TEST 97575-15, HEPARIN ASSAY. This device is classified as a Assay, Heparin (Class II - Special Controls, product code KFF).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on January 5, 1987, 69 days after receiving the submission on October 28, 1986.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7525.
| 510(k) Number | K864211 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 1986 |
| Decision Date | January 05, 1987 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | KFF — Assay, Heparin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7525 |