ENZYMATIC UREA NITROGEN REAGENT SET— 510(k) K860109

Name: FDA 510(k) clearance K860109
Creator: U.S. Food and Drug Administration
Published: 1986-02-06

Substantially Equivalent

Technostics Intl.

FDA 510(k) clearance K860109 for ENZYMATIC UREA NITROGEN REAGENT SET, Substantially Equivalent on 1986-02-06. Applicant: Technostics Intl.. Device class: 2.

Clearance details

Applicant: Technostics Intl.
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1986-01-13
Decision date: 1986-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, MI, US

Download summary PDF View on FDA.gov ↗

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