Atlas FDA

OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524

FDA 510(k) clearance K041793 · decided 2004-07-16

Clearance details

K-number
K041793
Device name
OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524
Applicant
Olympus America, Inc.
Decision
Substantially Equivalent
Date received
2004-07-02
Decision date
2004-07-16
Days to decision
14 days
Clearance type
Special
Product code
JMO
Device class
1
Regulation number
862.1415
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Irving, TX, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205, recall (Z-2264-2025)Beckman Coulter Inc.2025-08-04