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FDA 510(k)

Simplexa VZV Direct, Simplexa VZV Positive Control Pack

K-Number: K190219 · 2019-05-13

ApplicantDiasorin Molecular, LLC
Decision Date2019-05-13
Product CodePLO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Simplexa VZV Direct, Simplexa VZV Positive Control Pack is a medical device manufactured by Diasorin Molecular, LLC. It received FDA 510(k) clearance on 2019-05-13 under approval number K190219. The device is classified under product code PLO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Simplexa VZV Direct, Simplexa VZV Positive Control Pack?

Simplexa VZV Direct, Simplexa VZV Positive Control Pack is a medical device that received FDA 510(k) clearance on 2019-05-13. It is manufactured by Diasorin Molecular, LLC. The 510(k) number is K190219.

When was Simplexa VZV Direct, Simplexa VZV Positive Control Pack approved by the FDA?

Simplexa VZV Direct, Simplexa VZV Positive Control Pack received FDA 510(k) clearance on 2019-05-13, under approval number K190219.

What company makes Simplexa VZV Direct, Simplexa VZV Positive Control Pack?

Simplexa VZV Direct, Simplexa VZV Positive Control Pack is manufactured by Diasorin Molecular, LLC.

What is the FDA product code for Simplexa VZV Direct, Simplexa VZV Positive Control Pack?

The FDA product code for Simplexa VZV Direct, Simplexa VZV Positive Control Pack is PLO.

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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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