K830749 is an FDA 510(k) clearance for the PLATELET AGGREGOMETER. 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 May 16, 1983, 68 days after receiving the submission on March 9, 1983.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6675.
| 510(k) Number | K830749 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 1983 |
| Decision Date | May 16, 1983 |
| Days to Decision | 68 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 |