K760159 is an FDA 510(k) clearance for the AGGREGOMETER, DUAL CHANNEL PLATELET. This device is classified as a Aggregrometer, Platelet (Class II - Special Controls, product code JBX).
Submitted by Chrono-Log Corp. (Havertown, US). The FDA issued a Cleared decision on July 20, 1976, 18 days after receiving the submission on July 2, 1976.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6675.
| 510(k) Number | K760159 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 1976 |
| Decision Date | July 20, 1976 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | JBX — Aggregrometer, Platelet |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.6675 |