FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M
K Number: K083463
·
Decision Mar 13, 2009
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
52
Applicant Total
92
Review Days
109
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Basic Information
- Device Name
- DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M
- K Number
- K083463
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5630
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Healthcare Diagnostics
- Date Received
- November 24, 2008
- Decision Date
- March 13, 2009
- Product Code
- JZG
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| JZG | System, Test, Beta-2-Microglobulin Immunological | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JZG), ordered by most recent decision date.
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QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307
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DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH
FDA 510(k)
FDA Class 2
·Immunology
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