K193041 is an FDA 510(k) clearance for the Hemochron Signature Elite. This device is classified as a System, Multipurpose For In Vitro Coagulation Studies (Class II - Special Controls, product code JPA).
Submitted by Accriva Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on November 22, 2019, 22 days after receiving the submission on October 31, 2019.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K193041 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2019 |
| Decision Date | November 22, 2019 |
| Days to Decision | 22 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 |