FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLINISTAT ALBUMIN REAGENT TEST
K Number: K896910
·
Decision Jan 18, 1990
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
119
Applicant Total
1
Review Days
38
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Basic Information
- Device Name
- CLINISTAT ALBUMIN REAGENT TEST
- K Number
- K896910
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1035
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Miles Diagnostics Div.
- Date Received
- December 11, 1989
- Decision Date
- January 18, 1990
- Product Code
- CIX
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CIX | Bromcresol Green Dye-Binding, Albumin | FDA class 2 | Clinical Chemistry |
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