MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER— 510(k) K003721
Substantially EquivalentOlympus America, Inc.
FDA 510(k) clearance K003721 for MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER, Substantially Equivalent on 2000-12-18. Applicant: Olympus America, Inc.. Device class: 1.
Clearance details
- Applicant
- Olympus America, Inc.
- Product code
- Code JJE
- Device class
- Class 1
- Regulation
- 21 CFR 862.2160
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Irving, TX, US
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- K130915 — XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK
- K131554 — RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT
- K130276 — DIMENSION EXL WITH LM SYSTEM
More clearances from Olympus America, Inc.
view allAdverse events under product code JJE
product code JJE- Death
- 6
- Injury
- 441
- Malfunction
- 25,011
- Other
- 1
- Total
- 25,459
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K003721
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 K003721.
Data sourced from openFDA. This site is unofficial and independent of the FDA.