K990449 is an FDA 510(k) clearance for the HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE. 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 April 13, 1999, 60 days after receiving the submission on February 12, 1999.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K990449 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 1999 |
| Decision Date | April 13, 1999 |
| Days to Decision | 60 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 |