FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3
K Number: K121588
·
Decision Jun 20, 2012
Classifications
1
FEI Numbers
280
Registration Numbers
280
Same Product Code
492
Applicant Total
110
Review Days
20
Basic Information
- Device Name
- RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3
- K Number
- K121588
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- RANDOX LABORATORIES, LTD.
- Date Received
- May 31, 2012
- Decision Date
- June 20, 2012
- Product Code
- JJX
- 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 |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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