FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAT (TM) MICROALBUMIN TEST
K Number: K875161
·
Decision Feb 17, 1988
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
36
Applicant Total
12
Review Days
64
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Basic Information
- Device Name
- MAT (TM) MICROALBUMIN TEST
- K Number
- K875161
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5040
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Wampole Laboratories
- Date Received
- December 15, 1987
- Decision Date
- February 17, 1988
- 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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