CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER— 510(k) K062737
Substantially EquivalentHoriba Abx
FDA 510(k) clearance K062737 for CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER, Substantially Equivalent on 2007-06-12. Applicant: Horiba Abx. Device class: 2.
Clearance details
- Applicant
- Horiba Abx
- Product code
- Code CGS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montpellier, FR
Recent devices under product code CGS
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