FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2
K Number: K110846
·
Decision Sep 30, 2011
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
60
Applicant Total
18
Review Days
186
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Basic Information
- Device Name
- RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2
- K Number
- K110846
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Randox Laboratories Limited
- Date Received
- March 28, 2011
- Decision Date
- September 30, 2011
- Product Code
- JJW
- 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 |
|---|---|---|---|
| JJW | Urinalysis Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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