FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL
K Number: K110530
·
Decision Apr 30, 2012
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
158
Applicant Total
17
Review Days
431
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Basic Information
- Device Name
- ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL
- K Number
- K110530
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 862.1225
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- HORIBA ABX SAS
- Date Received
- February 24, 2011
- Decision Date
- April 30, 2012
- Product Code
- CGX
- 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 |
|---|---|---|---|
| CGX | Alkaline Picrate, Colorimetry, Creatinine | FDA class 2 | Clinical Chemistry |
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