OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL— 510(k) K070453

Name: FDA 510(k) clearance K070453
Creator: U.S. Food and Drug Administration
Published: 2007-06-11

Substantially Equivalent

Olympus Life & Material Science Europa GmbH (Irish

FDA 510(k) clearance K070453 for OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL, Substantially Equivalent on 2007-06-11. Applicant: Olympus Life & Material Science Europa GmbH (Irish. Device class: 2.

Clearance details

Applicant: Olympus Life & Material Science Europa GmbH (Irish
Product code: Code GHH
Device class: Class 2
Regulation: 21 CFR 864.7320
Advisory panel: Hematology
Date received: 2007-02-16
Decision date: 2007-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

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