ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL— 510(k) K060434
Substantially EquivalentHoriba Abx
FDA 510(k) clearance K060434 for ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL, Substantially Equivalent on 2007-06-05. Applicant: Horiba Abx. Device class: 2.
Clearance details
- Applicant
- Horiba Abx
- Product code
- Code CIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1035
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montpellier, FR
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Data sourced from openFDA. This site is unofficial and independent of the FDA.