FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLOOD GROUPING SYS., BG-9
K Number: K771098
·
Decision Aug 4, 1977
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
3
Applicant Total
157
Review Days
45
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Basic Information
- Device Name
- BLOOD GROUPING SYS., BG-9
- K Number
- K771098
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.9175
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Technicon Instruments Corp.
- Date Received
- June 20, 1977
- Decision Date
- August 4, 1977
- Product Code
- KSZ
- 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 |
|---|---|---|---|
| KSZ | System, Test, Automated Blood Grouping And Antibody | FDA class 2 | Hematology |
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