The following data is part of a premarket notification filed by Chrono-log Corp. with the FDA for Platelet Aggregation Reagents.
| Device ID | K922800 |
| 510k Number | K922800 |
| Device Name: | PLATELET AGGREGATION REAGENTS |
| Classification | Reagent, Platelet Aggregation |
| Applicant | CHRONO-LOG CORP. 2 WEST PARK RD. Havertown, PA 19083 |
| Contact | Aurthur Freilich |
| Correspondent | Aurthur 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 | 1992-06-10 |
| Decision Date | 1992-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811476010307 | K922800 | 000 |
| 00811476010147 | K922800 | 000 |
| 00811476010086 | K922800 | 000 |
| 00811476010062 | K922800 | 000 |
| 00811476010055 | K922800 | 000 |
| 00811476010048 | K922800 | 000 |