FDA 510(k)

Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit

K-Number: K233453 · 2024-07-10

Decision Date2024-07-10

Product CodeQQX

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit is a medical device manufactured by Life Technologies Corporation. It received FDA 510(k) clearance on 2024-07-10 under approval number K233453. The device is classified under product code QQX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit?

Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit is a medical device that received FDA 510(k) clearance on 2024-07-10. It is manufactured by Life Technologies Corporation. The 510(k) number is K233453.

When was Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit approved by the FDA?

Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit received FDA 510(k) clearance on 2024-07-10, under approval number K233453.

What company makes Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit?

Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit is manufactured by Life Technologies Corporation.

What is the FDA product code for Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit?

The FDA product code for Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit is QQX.

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Other Devices by Life Technologies Corporation

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Related Devices (Code: QQX)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.