ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT— 510(k) K073309

Substantially Equivalent

Horiba 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.

Clearance details

Applicant
Horiba Abx
Product code
Code LCP
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Montpellier, FR
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