TRIGLYCERIDE'S TEST (TRIGLI-CINET)— 510(k) K854783

Name: FDA 510(k) clearance K854783
Creator: U.S. Food and Drug Administration
Published: 1986-01-22

Substantially Equivalent

Sclavo, Inc.

FDA 510(k) clearance K854783 for TRIGLYCERIDE'S TEST (TRIGLI-CINET), Substantially Equivalent on 1986-01-22. Applicant: Sclavo, Inc.. Device class: 1.

Clearance details

Applicant: Sclavo, Inc.
Product code: Code CDT
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 1985-11-29
Decision date: 1986-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayne, NJ, US

Download summary PDF View on FDA.gov ↗

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