UREA NITROGEN REAGENT SET— 510(k) K840064

Name: FDA 510(k) clearance K840064
Creator: U.S. Food and Drug Administration
Published: 1984-06-14

Substantially Equivalent

Sterling Biochemical, Inc.

FDA 510(k) clearance K840064 for UREA NITROGEN REAGENT SET, Substantially Equivalent on 1984-06-14. Applicant: Sterling Biochemical, Inc.. Device class: 2.

Clearance details

Applicant: Sterling Biochemical, Inc.
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1984-01-09
Decision date: 1984-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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