The following data is part of a premarket notification filed by Chrono-log Corp. with the FDA for Kit, Platelet Aggregation Reagent (#390).
| Device ID | K760198 |
| 510k Number | K760198 |
| Device Name: | KIT, PLATELET AGGREGATION REAGENT (#390) |
| Classification | Reagent, Platelet Aggregation |
| Applicant | CHRONO-LOG CORP. 2 WEST PARK RD. Havertown, PA 19083 |
| Contact | Arthur Freilich |
| Correspondent | Arthur Freilich CHRONO-LOG CORP. 2 WEST PARK RD. Havertown, PA 19083 |
| Product Code | GHR |
| CFR Regulation Number | 864.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-07-06 |
| Decision Date | 1976-07-19 |