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FDA 510(k)

Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer

K-Number: K191030 · 2020-02-21

ApplicantLife Technologies Corporation
Decision Date2020-02-21
Product CodePCA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer is a medical device manufactured by Life Technologies Corporation. It received FDA 510(k) clearance on 2020-02-21 under approval number K191030. The device is classified under product code PCA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer?

Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer is a medical device that received FDA 510(k) clearance on 2020-02-21. It is manufactured by Life Technologies Corporation. The 510(k) number is K191030.

When was Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer approved by the FDA?

Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer received FDA 510(k) clearance on 2020-02-21, under approval number K191030.

What company makes Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer?

Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer is manufactured by Life Technologies Corporation.

What is the FDA product code for Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer?

The FDA product code for Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer is PCA.

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Official Source

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