OLYMPUS CHOLESTEROL REAGENT— 510(k) K925603

Substantially Equivalent

Olympus Corp.

FDA 510(k) clearance K925603 for OLYMPUS CHOLESTEROL REAGENT, Substantially Equivalent on 1993-02-08. Applicant: Olympus Corp.. Device class: 1.

Clearance details

Applicant: Olympus Corp.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1992-11-05
Decision date: 1993-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Success, NY, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K925603

K-number listed on FDA's recall record

Z-1025-2015 — Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16Class II·Terminated·Beckman Coulter Inc.·20141215

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K925603.

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