The following data is part of a premarket notification filed by Chrono-log Corp. with the FDA for Platelet Aggregometers.
| Device ID | K820422 |
| 510k Number | K820422 |
| Device Name: | PLATELET AGGREGOMETERS |
| Classification | Reagent, Platelet Aggregation |
| Applicant | CHRONO-LOG CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GHR |
| CFR Regulation Number | 864.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-16 |
| Decision Date | 1982-03-16 |