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FDA 510(k)

Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack

K-Number: K183223 · 2018-12-19

ApplicantDiasorin Molecular, LLC
Decision Date2018-12-19
Product CodeOZZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack is a medical device manufactured by Diasorin Molecular, LLC. It received FDA 510(k) clearance on 2018-12-19 under approval number K183223. The device is classified under product code OZZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack is a medical device that received FDA 510(k) clearance on 2018-12-19. It is manufactured by Diasorin Molecular, LLC. The 510(k) number is K183223.

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

Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack received FDA 510(k) clearance on 2018-12-19, under approval number K183223.

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

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

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

The FDA product code for Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack is OZZ.

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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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