K180486 is an FDA 510(k) clearance for the HemosIL Factor XII Deficient Plasma. This device is classified as a Plasma, Coagulation Factor Deficient (Class II - Special Controls, product code GJT).
Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on March 22, 2018, 27 days after receiving the submission on February 23, 2018.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7290.
| 510(k) Number | K180486 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 2018 |
| Decision Date | March 22, 2018 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GJT — Plasma, Coagulation Factor Deficient |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7290 |