FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
IMMUNOGLOBULINS A
K Number: K873869
·
Decision Oct 13, 1987
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
53
Applicant Total
73
Review Days
50
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Basic Information
- Device Name
- IMMUNOGLOBULINS A
- K Number
- K873869
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Unipath , Ltd.
- Date Received
- August 24, 1987
- Decision Date
- October 13, 1987
- Product Code
- CZP
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| CZP | Iga, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
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WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD
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IGA
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