FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
RANDOX URINE CONTROLS
K Number: K043266
·
Decision Feb 15, 2005
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
60
Applicant Total
110
Review Days
81
Basic Information
- Device Name
- RANDOX URINE CONTROLS
- K Number
- K043266
- 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, LTD.
- Date Received
- November 26, 2004
- Decision Date
- February 15, 2005
- 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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