OLYMPUS UREA NITROGEN (BUN) REAGENT— 510(k) K922597

Name: FDA 510(k) clearance K922597
Creator: U.S. Food and Drug Administration
Published: 1992-07-10

Substantially Equivalent

Olympus Corp.

FDA 510(k) clearance K922597 for OLYMPUS UREA NITROGEN (BUN) REAGENT, Substantially Equivalent on 1992-07-10. Applicant: Olympus Corp.. Device class: 2.

Clearance details

Applicant: Olympus Corp.
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1992-06-02
Decision date: 1992-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Success, NY, US

Download summary PDF View on FDA.gov ↗

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