TRIGLYCERIDE REAGENT SET— 510(k) K812838

Name: FDA 510(k) clearance K812838
Creator: U.S. Food and Drug Administration
Published: 1981-12-03

Substantially Equivalent

Anco Medical Reagents & Assoc.

FDA 510(k) clearance K812838 for TRIGLYCERIDE REAGENT SET, Substantially Equivalent on 1981-12-03. Applicant: Anco Medical Reagents & Assoc.. Device class: 1.

Clearance details

Applicant: Anco Medical Reagents & Assoc.
Product code: Code CDT
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 1981-10-09
Decision date: 1981-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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