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FDA 510(k)

Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)

K-Number: K241580 · 2024-12-06

ApplicantAbbott Molecular
Decision Date2024-12-06
Product CodeQQX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) is a medical device manufactured by Abbott Molecular. It received FDA 510(k) clearance on 2024-12-06 under approval number K241580. 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 Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)?

Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) is a medical device that received FDA 510(k) clearance on 2024-12-06. It is manufactured by Abbott Molecular. The 510(k) number is K241580.

When was Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) approved by the FDA?

Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) received FDA 510(k) clearance on 2024-12-06, under approval number K241580.

What company makes Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)?

Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) is manufactured by Abbott Molecular.

What is the FDA product code for Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)?

The FDA product code for Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) is QQX.

Other Devices by Abbott Molecular

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Related Devices (Code: QQX)

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Official Source

View on FDA Database →

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

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