OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL CALIBRATOR ODC0023— 510(k) K040692
Substantially EquivalentOlympus America, Inc.
FDA 510(k) clearance K040692 for OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL CALIBRATOR ODC0023, Substantially Equivalent on 2004-04-08. Applicant: Olympus America, Inc.. Device class: 2.
Clearance details
- Applicant
- Olympus America, Inc.
- Product code
- Code JIT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Irving, TX, US
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