K854079 is an FDA 510(k) clearance for the THROMBO SCREEN SICKLE CELL ASSAY SET. This device is classified as a Test, Sickle Cell (Class II - Special Controls, product code GHM).
Submitted by Pacific Hemostasis (Ventura, US). The FDA issued a Cleared decision on October 31, 1985, 24 days after receiving the submission on October 7, 1985.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7825.
| 510(k) Number | K854079 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 1985 |
| Decision Date | October 31, 1985 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GHM — Test, Sickle Cell |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7825 |