TRIGLYCERIDE (TRINDER) PROCEDURE— 510(k) K863254

Name: FDA 510(k) clearance K863254
Creator: U.S. Food and Drug Administration
Published: 1986-09-26

Substantially Equivalent

Data Medical Associates, Inc.

FDA 510(k) clearance K863254 for TRIGLYCERIDE (TRINDER) PROCEDURE, Substantially Equivalent on 1986-09-26. Applicant: Data Medical Associates, Inc.. Device class: 1.

Clearance details

Applicant: Data Medical Associates, Inc.
Product code: Code CDT
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 1986-08-25
Decision date: 1986-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TX, US

Download summary PDF View on FDA.gov ↗

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