FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS
K Number: K080485
·
Decision Dec 4, 2008
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
138
Applicant Total
1
Review Days
286
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Basic Information
- Device Name
- ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS
- K Number
- K080485
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1100
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diasys Diagnostics Systems GmbH
- Date Received
- February 22, 2008
- Decision Date
- December 4, 2008
- Product Code
- CIT
- 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 |
|---|---|---|---|
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | FDA class 2 | Clinical Chemistry |
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