K760198 is an FDA 510(k) clearance for the KIT, PLATELET AGGREGATION REAGENT (#390). This device is classified as a Reagent, Platelet Aggregation (Class II - Special Controls, product code GHR).
Submitted by Chrono-Log Corp. (Havertown, US). The FDA issued a Cleared decision on July 19, 1976, 13 days after receiving the submission on July 6, 1976.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5700.
| 510(k) Number | K760198 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 1976 |
| Decision Date | July 19, 1976 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GHR — Reagent, Platelet Aggregation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5700 |