OLYMPUS MAGNESIUM REAGENT— 510(k) K944407

Name: FDA 510(k) clearance K944407
Creator: U.S. Food and Drug Administration
Published: 1994-12-27

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K944407 for OLYMPUS MAGNESIUM REAGENT, Substantially Equivalent on 1994-12-27. Applicant: Olympus America, Inc.. Device class: 1.

Clearance details

Applicant: Olympus America, Inc.
Product code: Code JGJ
Device class: Class 1
Regulation: 21 CFR 862.1495
Advisory panel: Clinical Chemistry
Date received: 1994-09-08
Decision date: 1994-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Success, NY, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K944407

K-number listed on FDA's recall record

Z-0692-2022 — AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850Class II·Terminated·Beckman Coulter Inc.·20211208

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K944407.

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