UREA NITROGEN REAGENT— 510(k) K944250

Substantially Equivalent

Olympus Corp of America

FDA 510(k) clearance K944250 for UREA NITROGEN REAGENT, Substantially Equivalent on 1995-02-08. Applicant: Olympus Corp of America. Device class: 2.

Clearance details

Applicant: Olympus Corp of America
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1994-09-01
Decision date: 1995-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Success, NY, US

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