OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT— 510(k) K954537

Name: FDA 510(k) clearance K954537
Creator: U.S. Food and Drug Administration
Published: 1996-02-14

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K954537 for OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT, Substantially Equivalent on 1996-02-14. 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: 1995-09-29
Decision date: 1996-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

Download summary PDF View on FDA.gov ↗

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