K201570 is an FDA 510(k) clearance for the PF4 Enhanced assay. This device is classified as a Platelet Factor 4 Radioimmunoassay (Class II - Special Controls, product code LCO).
Submitted by Immucor Gti Diagnostics, Inc. (Waukesha, US). The FDA issued a Cleared decision on September 11, 2020, 92 days after receiving the submission on June 11, 2020.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7695.
| 510(k) Number | K201570 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 2020 |
| Decision Date | September 11, 2020 |
| Days to Decision | 92 days |
| Submission Type | Special |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | LCO - Platelet Factor 4 Radioimmunoassay |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7695 |