K820422 is an FDA 510(k) clearance for the PLATELET AGGREGOMETERS. This device is classified as a Reagent, Platelet Aggregation (Class II - Special Controls, product code GHR).
Submitted by Chrono-Log Corp. (Walker, US). The FDA issued a Cleared decision on March 16, 1982, 28 days after receiving the submission on February 16, 1982.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5700.
| 510(k) Number | K820422 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 16, 1982 |
| Decision Date | March 16, 1982 |
| Days to Decision | 28 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 |