FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇷 Argentina
WIENER LAB. URINE STRIP 10 AND 11
K Number: K083724
·
Decision Sep 2, 2009
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
10
Applicant Total
1
Review Days
261
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Basic Information
- Device Name
- WIENER LAB. URINE STRIP 10 AND 11
- K Number
- K083724
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.6550
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wiener Laboratorios Saic
- Date Received
- December 15, 2008
- Decision Date
- September 2, 2009
- Product Code
- JIO
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| JIO | Blood, Occult, Colorimetric, In Urine | FDA class 2 | Hematology |
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