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FDA 510(k)

Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack

K-Number: K192376 · 2019-11-26

ApplicantDiasorin Molecular, LLC
Decision Date2019-11-26
Product CodePGI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack is a medical device manufactured by Diasorin Molecular, LLC. It received FDA 510(k) clearance on 2019-11-26 under approval number K192376. The device is classified under product code PGI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack is a medical device that received FDA 510(k) clearance on 2019-11-26. It is manufactured by Diasorin Molecular, LLC. The 510(k) number is K192376.

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

Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack received FDA 510(k) clearance on 2019-11-26, under approval number K192376.

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

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

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

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

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Related Devices (Code: PGI)

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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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