Study, Platelet Adhesive
A platelet adhesive study device is used to measure the ability of platelets to adhere to surfaces under controlled flow conditions, evaluating an important aspect of primary hemostasis that may be impaired in conditions such as von Willebrand disease and other platelet disorders. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance before marketing. The product code is JBZ, regulated under 21 CFR 864.6650, within the Hematology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- JBZ
- Device Class
- FDA class 2
- Regulation Number
- 864.6650
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K800037 | PLATELET RETENTION (ADHESION) COLUMNS | Feb 05, 1980 | Substantially Equivalent | Hemometrix |
| K771678 | THROMBO-SCREEN PLATELET ADHESION | Nov 22, 1977 | Substantially Equivalent | Bay Area Hema. Onco. Clinic. & Res. L |
| K771523 | LATELET RETENTION COLUMN | Nov 22, 1977 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.