OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)— 510(k) K030045

Name: FDA 510(k) clearance K030045
Creator: U.S. Food and Drug Administration
Published: 2003-02-21

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K030045 for OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114), Substantially Equivalent on 2003-02-21. Applicant: Olympus America, Inc.. Device class: 1.

Clearance details

Applicant: Olympus America, Inc.
Product code: Code DIH
Device class: Class 1
Regulation: 21 CFR 862.3240
Advisory panel: Clinical Toxicology
Date received: 2003-01-06
Decision date: 2003-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

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