FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BUHLMANN ANGIOSTENSIN II RIA
K Number: K954299
·
Decision Oct 19, 1995
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
15
Applicant Total
4
Review Days
35
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Basic Information
- Device Name
- BUHLMANN ANGIOSTENSIN II RIA
- K Number
- K954299
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1085
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Buhlmann Laboratories AG
- Date Received
- September 14, 1995
- Decision Date
- October 19, 1995
- Product Code
- CIB
- 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 |
|---|---|---|---|
| CIB | Radioimmunoassay, Angiotensin I And Renin | FDA class 2 | Clinical Chemistry |
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