Medical Device Manufacturer · US , Grand Island , NY

Life Technologies Corporation

7 submissions · 7 cleared · Since 2010

Total

Cleared

Denied

Life Technologies Corporation — FDA 510(k) Submissions

Life Technologies Corporation has submitted 7 FDA 510(k) premarket notifications since 2010, of which 7 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Media, Culture, Ex Vivo, Tissue And Cell, Real Time Nucleic Acid Amplification System, High Throughput Dna Sequence Analyzer, Dna Genetic Analyzer, Respiratory Specimen Nucleic Acid Sars-cov-2 Test . Use the specialty filter in the sidebar to narrow results.

7 devices

1–7 of 7

Applied Biosystems? TaqPath? COVID-19, Flu A, Flu B, RSV Select Panel

K241806 · QOF Multi-target Respiratory... · Microbiology

Jan 2025 201d

Applied Biosystems? TaqPath? COVID-19 Diagnostic PCR Kit

K233453 · QQX Respiratory Specimen... · Microbiology

Jul 2024 264d

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

K191030 · PCA Dna Genetic Analyzer · Toxicology

Feb 2020 309d

Ion PGM Dx System

K170299 · PFF High Throughput Dna... · Chemistry

Jun 2017 142d

QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT

K123955 · OOI Real Time Nucleic Acid... · Microbiology

Mar 2013 77d

STEMPRO MSC SFM

K103302 · NDS Media, Culture, Ex Vivo,... · Gastroenterology & Urology

Feb 2011 101d

KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618

K100616 · NDS Media, Culture, Ex Vivo,... · Gastroenterology & Urology

May 2010 77d

Life Technologies Corporation

Life Technologies Corporation — FDA 510(k) Submissions

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