FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VANTERA CLINICAL ANALYZER
K Number: K133849
·
Decision Oct 22, 2014
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
12
Applicant Total
3
Review Days
307
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Basic Information
- Device Name
- VANTERA CLINICAL ANALYZER
- K Number
- K133849
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.2570
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Liposcience
- Date Received
- December 19, 2013
- Decision Date
- October 22, 2014
- Product Code
- NSU
- 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 |
|---|---|---|---|
| NSU | Instrumentation For Clinical Multiplex Test Systems | FDA class 2 | Clinical Chemistry |
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