The following data is part of a premarket notification filed by Hemometrix with the FDA for Platelet Retention (adhesion) Columns.
| Device ID | K800037 |
| 510k Number | K800037 |
| Device Name: | PLATELET RETENTION (ADHESION) COLUMNS |
| Classification | Study, Platelet Adhesive |
| Applicant | HEMOMETRIX 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JBZ |
| CFR Regulation Number | 864.6650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-01-07 |
| Decision Date | 1980-02-05 |