OLYMPUS IGA REAGENT— 510(k) K073489

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K073489 for OLYMPUS IGA REAGENT, Substantially Equivalent on 2008-02-11. Applicant: Olympus America, Inc.. Device class: 2.

Clearance details

Applicant: Olympus America, Inc.
Product code: Code CFN
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 2007-12-12
Decision date: 2008-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Co. Clare, IE

Download summary PDF View on FDA.gov ↗

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More clearances from Olympus America, Inc.

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Recalls naming K073489

K-number listed on FDA's recall record

Z-2488-2023 — Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2Class II·Ongoing·Beckman Coulter Inc.·20230712

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K073489.

Data sourced from openFDA. This site is unofficial and independent of the FDA.