FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2
K Number: K043267
·
Decision Feb 10, 2005
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
15
Applicant Total
116
Review Days
76
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Basic Information
- Device Name
- POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2
- K Number
- K043267
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1600
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Randox Laboratories, Ltd.
- Date Received
- November 26, 2004
- Decision Date
- February 10, 2005
- Product Code
- CEJ
- 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 |
|---|---|---|---|
| CEJ | Tetraphenyl Borate, Colorimetry, Potassium | FDA class 2 | Clinical Chemistry |
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