The following data is part of a premarket notification filed by Pacific Hemostasis with the FDA for Platelet Aggregation Reagents.
| Device ID | K800146 |
| 510k Number | K800146 |
| Device Name: | PLATELET AGGREGATION REAGENTS |
| Classification | System, Automated Platelet Aggregation |
| Applicant | PACIFIC HEMOSTASIS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JOZ |
| CFR Regulation Number | 864.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-01-22 |
| Decision Date | 1980-02-05 |