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FDA 510(k)

Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack

K-Number: K202755 · 2022-11-05

ApplicantDiasorin Molecular, LLC
Decision Date2022-11-05
Product CodeQDZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack is a medical device manufactured by Diasorin Molecular, LLC. It received FDA 510(k) clearance on 2022-11-05 under approval number K202755. The device is classified under product code QDZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack?

Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack is a medical device that received FDA 510(k) clearance on 2022-11-05. It is manufactured by Diasorin Molecular, LLC. The 510(k) number is K202755.

When was Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack approved by the FDA?

Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack received FDA 510(k) clearance on 2022-11-05, under approval number K202755.

What company makes Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack?

Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack is manufactured by Diasorin Molecular, LLC.

What is the FDA product code for Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack?

The FDA product code for Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack is QDZ.

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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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