FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TOTAL PROTEIN URINE/CSF GEN.3
K Number: K141925
·
Decision Dec 9, 2014
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
12
Applicant Total
14
Review Days
146
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Basic Information
- Device Name
- TOTAL PROTEIN URINE/CSF GEN.3
- K Number
- K141925
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 862.1645
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Operations (Rdo)
- Date Received
- July 16, 2014
- Decision Date
- December 9, 2014
- Product Code
- JIQ
- 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 |
|---|---|---|---|
| JIQ | Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JIQ), ordered by most recent decision date.
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WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR
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URINARY ALBUMIN TEST PACK
FDA 510(k)
FDA Class 1
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