ENZYMATIC CHOLESTROL REAGENT SET— 510(k) K855187

Name: FDA 510(k) clearance K855187
Creator: U.S. Food and Drug Administration
Published: 1986-01-14

Substantially Equivalent

Technostics Intl.

FDA 510(k) clearance K855187 for ENZYMATIC CHOLESTROL REAGENT SET, Substantially Equivalent on 1986-01-14. Applicant: Technostics Intl.. Device class: 1.

Clearance details

Applicant: Technostics Intl.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1985-12-26
Decision date: 1986-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, MI, US

Download summary PDF View on FDA.gov ↗

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