K153137 is an FDA 510(k) clearance for the HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls. This device is classified as a Platelet Factor 4 Radioimmunoassay (Class II - Special Controls, product code LCO).
Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on July 8, 2016, 252 days after receiving the submission on October 30, 2015.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7695.
| 510(k) Number | K153137 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 2015 |
| Decision Date | July 08, 2016 |
| Days to Decision | 252 days |
| Submission Type | Traditional |
| 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 |