TRIGLYCERIDE DIAGNOSTIC KIT— 510(k) K830288

Substantially Equivalent

Sclavo, Inc.

FDA 510(k) clearance K830288 for TRIGLYCERIDE DIAGNOSTIC KIT, Substantially Equivalent on 1983-02-25. 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: 1983-01-27
Decision date: 1983-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.