K160502 is an FDA 510(k) clearance for the TEG 6s Hemostasis System. 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 April 19, 2017, 421 days after receiving the submission on February 23, 2016.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K160502 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 2016 |
| Decision Date | April 19, 2017 |
| Days to Decision | 421 days |
| Submission Type | Special |
| 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 |