OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT— 510(k) K002918

Name: FDA 510(k) clearance K002918
Creator: U.S. Food and Drug Administration
Published: 2000-10-25

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K002918 for OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT, Substantially Equivalent on 2000-10-25. Applicant: Olympus America, Inc.. Device class: 2.

Clearance details

Applicant: Olympus America, Inc.
Product code: Code DCN
Device class: Class 2
Regulation: 21 CFR 866.5270
Advisory panel: Immunology
Date received: 2000-09-19
Decision date: 2000-10-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

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