FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN
K Number: K110137
·
Decision Aug 10, 2011
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
48
Applicant Total
17
Review Days
204
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Basic Information
- Device Name
- ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN
- K Number
- K110137
- 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
- January 18, 2011
- Decision Date
- August 10, 2011
- Product Code
- JFY
- 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 |
|---|---|---|---|
| JFY | Enzymatic Method, Creatinine | FDA class 2 | Clinical Chemistry |
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| K191245 | Yumizen C1200 ALP, Yumizen C1200 Albumin | Aug 30, 2019 | Substantially Equivalent |
| K191396 | Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe | Jul 26, 2019 | Substantially Equivalent |
| K170353 | ABX MICROS ES 60 OT and ABX MICROS ES 60 CT | Nov 1, 2017 | Substantially Equivalent |
| K151133 | PENTRA XLR | Dec 9, 2015 | Substantially Equivalent |