OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL— 510(k) K070453
Substantially EquivalentOlympus 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.
Clearance details
- Applicant
- Olympus Life & Material Science Europa GmbH (Irish
- Product code
- Code GHH
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irving, TX, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.