PERIDOCHROM TRIGLYCERIDES GPO— 510(k) K850667

Name: FDA 510(k) clearance K850667
Creator: U.S. Food and Drug Administration
Published: 1985-03-11

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K850667 for PERIDOCHROM TRIGLYCERIDES GPO, Substantially Equivalent on 1985-03-11. Applicant: Boehringer Mannheim Corp.. Device class: 1.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code CDT
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 1985-02-20
Decision date: 1985-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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