OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105.— 510(k) K060201
Substantially EquivalentOlympus America, Inc.
FDA 510(k) clearance K060201 for OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105., Substantially Equivalent on 2006-06-06. Applicant: Olympus America, Inc.. Device class: 2.
Clearance details
- Applicant
- Olympus America, Inc.
- Product code
- Code DHR
- Device class
- Class 2
- Regulation
- 21 CFR 866.5775
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irving, TX, US
Recent devices under product code DHR
view allMore clearances from Olympus America, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.