OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER— 510(k) K011720
Substantially EquivalentOlympus America, Inc.
FDA 510(k) clearance K011720 for OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER, Substantially Equivalent on 2001-06-25. Applicant: Olympus America, Inc.. Device class: 2.
Clearance details
- Applicant
- Olympus America, Inc.
- Product code
- Code CIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1035
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Irving, TX, US
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More clearances from Olympus America, Inc.
view allRecalls naming K011720
K-number listed on FDA's recall record- Z-0152-2014 — ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.
- Z-1430-2013 — AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and other body fluids, including whole blood.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K011720.
Data sourced from openFDA. This site is unofficial and independent of the FDA.