FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
RANDOX C-REACTIVE PROTEIN CALIBRATOR
K Number: K022682
·
Decision Nov 5, 2002
Classifications
1
FEI Numbers
76
Registration Numbers
76
Same Product Code
129
Applicant Total
110
Review Days
85
Basic Information
- Device Name
- RANDOX C-REACTIVE PROTEIN CALIBRATOR
- K Number
- K022682
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- RANDOX LABORATORIES, LTD.
- Date Received
- August 12, 2002
- Decision Date
- November 5, 2002
- Product Code
- JIS
- 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 |
|---|---|---|---|
| JIS | Calibrator, Primary | FDA class 2 | Clinical Chemistry |
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