OLYMPUS PREALBUMIN CALIBRATOR, ODR3029— 510(k) K032285
Substantially EquivalentOlympus America, Inc.
FDA 510(k) clearance K032285 for OLYMPUS PREALBUMIN CALIBRATOR, ODR3029, Substantially Equivalent on 2003-08-21. 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
- Abbreviated
- Location
- Irving, TX, US
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