TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL— 510(k) K905226

Name: FDA 510(k) clearance K905226
Creator: U.S. Food and Drug Administration
Published: 1990-12-11

Substantially Equivalent

Enzyme Technology, Inc.

FDA 510(k) clearance K905226 for TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL, Substantially Equivalent on 1990-12-11. Applicant: Enzyme Technology, Inc.. Device class: 1.

Clearance details

Applicant: Enzyme Technology, Inc.
Product code: Code JGY
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 1990-11-20
Decision date: 1990-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shelton, CT, US

Download summary PDF View on FDA.gov ↗

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