LINEAR ENZYMATIC CHOLESTEROL SYSTEM— 510(k) K800199

Name: FDA 510(k) clearance K800199
Creator: U.S. Food and Drug Administration
Published: 1980-02-21

Substantially Equivalent

Simmler, Inc.

FDA 510(k) clearance K800199 for LINEAR ENZYMATIC CHOLESTEROL SYSTEM, Substantially Equivalent on 1980-02-21. Applicant: Simmler, Inc.. Device class: 1.

Clearance details

Applicant: Simmler, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1980-01-30
Decision date: 1980-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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