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FDA 510(k) K191030 — Applied Biosystems 3500 Dx Genetic Analyzer and Applied Biosystems 3500xL Dx Genetic Analyzer
FDA 510(k) index record K191030. Device: Applied Biosystems 3500 Dx Genetic Analyzer and Applied Biosystems 3500xL Dx Genetic Analyzer. Applicant as listed: Life Technologies Corporation. Decision date: 2020-02-21.
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"device_name": "Applied Biosystems 3500 Dx Genetic Analyzer and Applied Biosystems 3500xL Dx Genetic Analyzer"
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2026-10-20
2026-10-20
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FDA 510(k) public index record K191030.
Device name: Applied Biosystems 3500 Dx Genetic Analyzer and Applied Biosystems 3500xL Dx Genetic Analyzer. Applicant as listed: Life Technologies Corporation.
Decision date: 2020-02-21. Decision wording: Substantially Equivalent.
Product code: PCA. Regulation: 21 CFR 862.2570. Medical specialty: Clinical Chemistry.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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