K960749 is an FDA 510(k) clearance for the HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT. This device is classified as a Activated Whole Blood Clotting Time (Class II — Special Controls, product code JBP).
Submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on August 12, 1996, 171 days after receiving the submission on February 23, 1996.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7140.
| 510(k) Number | K960749 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 1996 |
| Decision Date | August 12, 1996 |
| Days to Decision | 171 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | JBP — Activated Whole Blood Clotting Time |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.7140 |