FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT
K Number: K761058
·
Decision Feb 7, 1977
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
189
Applicant Total
37
Review Days
81
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Basic Information
- Device Name
- QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT
- K Number
- K761058
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7290
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Bio/Data Corp.
- Date Received
- November 18, 1976
- Decision Date
- February 7, 1977
- Product Code
- GGP
- 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 |
|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | FDA class 2 | Hematology |
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