OLYMPUS TRIGLYCERIDE TEST SYSTEM— 510(k) K063804

Name: FDA 510(k) clearance K063804
Creator: U.S. Food and Drug Administration
Published: 2007-03-23

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K063804 for OLYMPUS TRIGLYCERIDE TEST SYSTEM, Substantially Equivalent on 2007-03-23. Applicant: Olympus America, Inc.. Device class: 1.

Clearance details

Applicant: Olympus America, Inc.
Product code: Code CDT
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 2006-12-22
Decision date: 2007-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K063804

K-number listed on FDA's recall record

Z-1934-2016 — Triglyceride, Catalog No. OSR6x118 Product Usage:Triglyceride OSR6x118 is intended as an Enzymatic colour test for the quantitative determination of triglyceride in human serum and plasma on Beckman Coulter AU analyzers.Class II·Terminated·Beckman Coulter Inc.·20160413

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K063804.

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