OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117— 510(k) K061575
Substantially EquivalentOlympus America, Inc.
FDA 510(k) clearance K061575 for OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117, Substantially Equivalent on 2006-10-05. Applicant: Olympus America, Inc.. Device class: 2.
Clearance details
- Applicant
- Olympus America, Inc.
- Product code
- Code CJY
- Device class
- Class 2
- Regulation
- 21 CFR 862.1145
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irving, TX, US
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