FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUANTIGEN T & B CELL ASSAY
K Number: K831053
·
Decision Aug 8, 1983
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
6
Applicant Total
319
Review Days
129
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Basic Information
- Device Name
- QUANTIGEN T & B CELL ASSAY
- K Number
- K831053
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Bio-Rad
- Date Received
- April 1, 1983
- Decision Date
- August 8, 1983
- Product Code
- LIZ
- Advisory Committee
- Hematology
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| LIZ | Assay, T Lymphocyte Surface Marker | FDA class 2 | Hematology |
Similar 510(k) Clearances
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