K183390 is an FDA 510(k) clearance for the QNext and DG-PT. This device is classified as a System, Multipurpose For In Vitro Coagulation Studies (Class II - Special Controls, product code JPA).
Submitted by Diagnostic Grifols, S.A. (Partes Del Valles, ES). The FDA issued a Cleared decision on August 21, 2019, 258 days after receiving the submission on December 6, 2018.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K183390 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2018 |
| Decision Date | August 21, 2019 |
| Days to Decision | 258 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | JPA - System, Multipurpose For In Vitro Coagulation Studies |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5425 |