FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PATHFAST HSCRP
K Number: K083412
·
Decision Mar 9, 2009
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
69
Applicant Total
4
Review Days
111
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Basic Information
- Device Name
- PATHFAST HSCRP
- K Number
- K083412
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mitsubishi Kagaku Iatron
- Date Received
- November 18, 2008
- Decision Date
- March 9, 2009
- Product Code
- DCN
- 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 |
|---|---|---|---|
| DCN | System, Test, C-Reactive Protein | FDA class 2 | Immunology |
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