FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426
K Number: K071474
·
Decision Dec 10, 2008
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
1
Applicant Total
92
Review Days
561
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Basic Information
- Device Name
- DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426
- K Number
- K071474
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5600
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Healthcare Diagnostics
- Date Received
- May 29, 2007
- Decision Date
- December 10, 2008
- Product Code
- NTV
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| NTV | Myeloperoxidase, Immunoassay, System, Test | FDA class 2 | Immunology |
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