FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DIMENSION CLINICAL CHEMISTRY SYSTEM
K Number: K112999
·
Decision Nov 22, 2011
Classifications
1
FEI Numbers
174
Registration Numbers
174
Same Product Code
207
Applicant Total
92
Review Days
46
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Basic Information
- Device Name
- DIMENSION CLINICAL CHEMISTRY SYSTEM
- K Number
- K112999
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 862.2160
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Healthcare Diagnostics
- Date Received
- October 7, 2011
- Decision Date
- November 22, 2011
- Product Code
- JJE
- 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 |
|---|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | FDA class 1 | Clinical Chemistry |
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