JBZ · Study, Platelet Adhesive
Hematology · 21 CFR 864.6650 · Class 2
Overview
| Product Code | JBZ |
|---|---|
| Device Name | Study, Platelet Adhesive |
| Regulation | 21 CFR 864.6650 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
A platelet adhesion test is a device used to determine in vitro platelet function.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K800037 | PLATELET RETENTION (ADHESION) COLUMNS | Hemometrix | Feb 5, 1980 | SESE |
| K771678 | THROMBO-SCREEN PLATELET ADHESION | Bay Area Hema. Onco. Clinic. & Res. L | Nov 22, 1977 | SESE |
| K771523 | LATELET RETENTION COLUMN | Bd Becton Dickinson Vacutainer Systems Preanalytic | Nov 22, 1977 | SESE |
Top Applicants
- Bay Area Hema. Onco. Clinic. & Res. L — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Hemometrix — 1 clearance
