U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST— 510(k) K864231

Name: FDA 510(k) clearance K864231
Creator: U.S. Food and Drug Administration
Published: 1986-12-04

Substantially Equivalent

U. S. Diagnostics, Inc.

FDA 510(k) clearance K864231 for U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST, Substantially Equivalent on 1986-12-04. Applicant: U. S. Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: U. S. Diagnostics, Inc.
Product code: Code CDT
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 1986-10-28
Decision date: 1986-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Luis Obispo, CA, US

Download summary PDF View on FDA.gov ↗

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