FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT
K Number: K131554
·
Decision Jan 9, 2014
Classifications
1
FEI Numbers
174
Registration Numbers
174
Same Product Code
207
Applicant Total
116
Review Days
224
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Basic Information
- Device Name
- RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT
- K Number
- K131554
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2160
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Randox Laboratories, Ltd.
- Date Received
- May 30, 2013
- Decision Date
- January 9, 2014
- Product Code
- JJE
- 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 |
|---|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | FDA class 1 | Clinical Chemistry |
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