Applied Biosystems 3500 Dx Genetic Analyzer and Applied Biosystems 3500xL Dx Genetic Analyzer— 510(k) K191030

Name: FDA 510(k) clearance K191030
Creator: U.S. Food and Drug Administration
Published: 2020-02-21

Substantially Equivalent

Life Technologies Corporation

FDA 510(k) clearance K191030 for Applied Biosystems 3500 Dx Genetic Analyzer and Applied Biosystems 3500xL Dx Genetic Analyzer, Substantially Equivalent on 2020-02-21. Applicant: Life Technologies Corporation. Device class: 2.

Clearance details

Applicant: Life Technologies Corporation
Product code: Code PCA
Device class: Class 2
Regulation: 21 CFR 862.2570
Advisory panel: Clinical Chemistry
Date received: 2019-04-18
Decision date: 2020-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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