OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524— 510(k) K041793
Substantially EquivalentOlympus America, Inc.
FDA 510(k) clearance K041793 for OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524, Substantially Equivalent on 2004-07-16. Applicant: Olympus America, Inc.. Device class: 1.
Clearance details
- Applicant
- Olympus America, Inc.
- Product code
- Code JMO
- Device class
- Class 1
- Regulation
- 21 CFR 862.1415
- 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 K041793
K-number listed on FDA's recall record- Z-2264-2025 — UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
- Z-3028-2020 — UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 - Product Usage: System reagent for the quantitative determination of Unsaturated Iron Binding Capacity (UIBC) in human serum and plasma on Beckman Coulter AU analyzers.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K041793.
Data sourced from openFDA. This site is unofficial and independent of the FDA.