OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER— 510(k) K981743
Substantially EquivalentOlympus America, Inc.
FDA 510(k) clearance K981743 for OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER, Substantially Equivalent on 1998-06-09. Applicant: Olympus America, Inc.. Device class: 2.
Clearance details
- Applicant
- Olympus America, Inc.
- Product code
- Code CKB
- Device class
- Class 2
- Regulation
- 21 CFR 862.1020
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Melville, NY, US
Recent devices under product code CKB
view allMore clearances from Olympus America, Inc.
view allRecalls naming K981743
K-number listed on FDA's recall record- Z-1907-2025 — Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
- 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-0153-2014 — ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K981743.
Data sourced from openFDA. This site is unofficial and independent of the FDA.