K010193 is an FDA 510(k) clearance for the HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS. This device is classified as a Assay, Heparin (Class II — Special Controls, product code KFF).
Submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on June 6, 2001, 135 days after receiving the submission on January 22, 2001.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7525.
| 510(k) Number | K010193 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 2001 |
| Decision Date | June 06, 2001 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | KFF — Assay, Heparin |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.7525 |