FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THROMBO-SCREEN PLATELET ADHESION
K Number: K771678
·
Decision Nov 22, 1977
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
2
Applicant Total
4
Review Days
81
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Basic Information
- Device Name
- THROMBO-SCREEN PLATELET ADHESION
- K Number
- K771678
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.6650
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Bay Area Hema. Onco. Clinic. & Res. L
- Date Received
- September 2, 1977
- Decision Date
- November 22, 1977
- Product Code
- JBZ
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JBZ | Study, Platelet Adhesive | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JBZ), ordered by most recent decision date.
PLATELET RETENTION (ADHESION) COLUMNS
FDA 510(k)
FDA Class 2
·Hematology
LATELET RETENTION COLUMN
FDA 510(k)
FDA Class 2
·Hematology