OLYMPUS CALCIUM ARSENAZO III REAGENT— 510(k) K982035

Name: FDA 510(k) clearance K982035
Creator: U.S. Food and Drug Administration
Published: 1998-06-24

Substantially Equivalent

Olympus Diagnostica GmbH

FDA 510(k) clearance K982035 for OLYMPUS CALCIUM ARSENAZO III REAGENT, Substantially Equivalent on 1998-06-24. Applicant: Olympus Diagnostica GmbH. Device class: 2.

Clearance details

Applicant: Olympus Diagnostica GmbH
Product code: Code CJY
Device class: Class 2
Regulation: 21 CFR 862.1145
Advisory panel: Clinical Chemistry
Date received: 1998-06-10
Decision date: 1998-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

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