K972831 is an FDA 510(k) clearance for the HEMOCHRON CITRATE APTT. This device is classified as a Activated Partial Thromboplastin (Class II — Special Controls, product code GFO).
Submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on November 20, 1997, 113 days after receiving the submission on July 30, 1997.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7925.
| 510(k) Number | K972831 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 1997 |
| Decision Date | November 20, 1997 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | GFO — Activated Partial Thromboplastin |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.7925 |