FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PAROS CRP
K Number: K022690
·
Decision Dec 23, 2002
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
69
Applicant Total
2
Review Days
132
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Basic Information
- Device Name
- PAROS CRP
- K Number
- K022690
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Horiba, Ltd.
- Date Received
- August 13, 2002
- Decision Date
- December 23, 2002
- Product Code
- DCN
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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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| K Number | Device Name | ||
|---|---|---|---|
| K183375 | Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode | Feb 12, 2019 | Substantially Equivalent |