FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUAN. COLOR. DETER. OF SERUM ALBUMIN
K Number: K771771
·
Decision Oct 7, 1977
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
36
Applicant Total
47
Review Days
18
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Basic Information
- Device Name
- QUAN. COLOR. DETER. OF SERUM ALBUMIN
- K Number
- K771771
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5040
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Stanbio Laboratory
- Date Received
- September 19, 1977
- Decision Date
- October 7, 1977
- Product Code
- DCF
- 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 |
|---|---|---|---|
| DCF | Albumin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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