The following data is part of a premarket notification filed by Chrono-log Corp. with the FDA for Platelet Aggregation Reagent.
| Device ID | K850592 |
| 510k Number | K850592 |
| Device Name: | PLATELET AGGREGATION REAGENT |
| Classification | Aggregrometer, Platelet |
| 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 | JBX |
| CFR Regulation Number | 864.6675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-15 |
| Decision Date | 1985-05-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811476010154 | K850592 | 000 |