K020798 is an FDA 510(k) clearance for the HEMOCHRON JR. SIGNATURE +. This device is classified as a System, Multipurpose For In Vitro Coagulation Studies (Class II - Special Controls, product code JPA).
Submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on March 28, 2002, 16 days after receiving the submission on March 12, 2002.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K020798 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 2002 |
| Decision Date | March 28, 2002 |
| Days to Decision | 16 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 |