OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032)— 510(k) K031380

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K031380 for OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032), Substantially Equivalent on 2003-11-14. Applicant: Olympus America, Inc..

Clearance details

Applicant: Olympus America, Inc.
Product code: Code LCP
Advisory panel: Hematology
Date received: 2003-05-01
Decision date: 2003-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

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