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FDA 510(k)

Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack

K-Number: K201505 · 2020-08-22

ApplicantDiasorin Molecular, LLC
Decision Date2020-08-22
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack is a medical device manufactured by Diasorin Molecular, LLC. It received FDA 510(k) clearance on 2020-08-22 under approval number K201505. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack?

Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack is a medical device that received FDA 510(k) clearance on 2020-08-22. It is manufactured by Diasorin Molecular, LLC. The 510(k) number is K201505.

When was Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack approved by the FDA?

Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack received FDA 510(k) clearance on 2020-08-22, under approval number K201505.

What company makes Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack?

Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack is manufactured by Diasorin Molecular, LLC.

What is the FDA product code for Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack?

The FDA product code for Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack is OCC.

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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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