FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR
K Number: K953212
·
Decision Jul 31, 1995
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
125
Applicant Total
110
Review Days
21
Basic Information
- Device Name
- C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR
- K Number
- K953212
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- RANDOX LABORATORIES, LTD.
- Date Received
- July 10, 1995
- Decision Date
- July 31, 1995
- Product Code
- DCK
- 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 |
|---|---|---|---|
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | FDA class 2 | Immunology |
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