K-number	K233453
Device name	Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit
Applicant	Life Technologies Corporation
Product code	QQX
Device class	Class II
Decision date	Jul 10, 2024
Decision	Substantially Equivalent
Regulation	866.3981

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Source

View the full FDA submission: accessdata.fda.gov

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Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit

Everything you need for a 510(k) submission. Nothing you don't.

Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit