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
- Product 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-3332-2026 — Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96692 / 14987666542965 B96693 / 14987666542972 B12183 / 14987666540671 The AU480 Chemistry Analyzer measure analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material, and other accessories. This system is for in vitro diagnostic use only.
- 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.