K972866 is an FDA 510(k) clearance for the HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT. This device is classified as a Test, Time, Prothrombin (Class II — Special Controls, product code GJS).
Submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on September 30, 1998, 422 days after receiving the submission on August 4, 1997.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7750.
| 510(k) Number | K972866 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 1997 |
| Decision Date | September 30, 1998 |
| Days to Decision | 422 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GJS — Test, Time, Prothrombin |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.7750 |