FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005
K Number: K061812
·
Decision Apr 6, 2007
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
80
Applicant Total
3
Review Days
284
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Basic Information
- Device Name
- COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005
- K Number
- K061812
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1340
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Analyticon Biotechnologies AG
- Date Received
- June 26, 2006
- Decision Date
- April 6, 2007
- Product Code
- JIL
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | FDA class 2 | Clinical Chemistry |
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