FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY;ADVIA CENTAUR VITD TOTAL CALIBRATORS,QUALITY CONTROL & MASTER CONTROL MATERIA
K Number: K133156
·
Decision Jul 24, 2014
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
45
Applicant Total
152
Review Days
280
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Basic Information
- Device Name
- ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY;ADVIA CENTAUR VITD TOTAL CALIBRATORS,QUALITY CONTROL & MASTER CONTROL MATERIA
- K Number
- K133156
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1825
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date Received
- October 17, 2013
- Decision Date
- July 24, 2014
- Product Code
- MRG
- 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 |
|---|---|---|---|
| MRG | System, Test, Vitamin D | FDA class 2 | Clinical Chemistry |
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