FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITROS Chemistry Products hsCRP Reagent
K Number: K160712
·
Decision Jul 14, 2017
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
125
Applicant Total
16
Review Days
486
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Basic Information
- Device Name
- VITROS Chemistry Products hsCRP Reagent
- K Number
- K160712
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ortho Clinical Diagnostics
- Date Received
- March 15, 2016
- Decision Date
- July 14, 2017
- Product Code
- DCK
- 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 |
|---|---|---|---|
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | FDA class 2 | Immunology |
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