K183160 is an FDA 510(k) clearance for the TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge. This device is classified as a System, Multipurpose For In Vitro Coagulation Studies (Class II - Special Controls, product code JPA).
Submitted by Haemonetics Corporation (Braintree, US). The FDA issued a Cleared decision on May 9, 2019, 175 days after receiving the submission on November 15, 2018.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K183160 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 2018 |
| Decision Date | May 09, 2019 |
| Days to Decision | 175 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 |