ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT— 510(k) K073309
Substantially EquivalentHoriba Abx
FDA 510(k) clearance K073309 for ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT, Substantially Equivalent on 2008-10-17. Applicant: Horiba Abx. Device class: 2.
Clearance details
- Applicant
- Horiba Abx
- Product code
- Code LCP
- Device class
- Class 2
- Regulation
- 21 CFR 864.7470
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montpellier, FR
Recent devices under product code LCP
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