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FDA 510(k)

Simplexa GBS Direct, Simplexa GBS Positive Control Pack

K-Number: K182467 · 2018-11-07

ApplicantDiasorin Molecular, LLC
Decision Date2018-11-07
Product CodeNJR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Simplexa GBS Direct, Simplexa GBS Positive Control Pack is a medical device manufactured by Diasorin Molecular, LLC. It received FDA 510(k) clearance on 2018-11-07 under approval number K182467. The device is classified under product code NJR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

Simplexa GBS Direct, Simplexa GBS Positive Control Pack is a medical device that received FDA 510(k) clearance on 2018-11-07. It is manufactured by Diasorin Molecular, LLC. The 510(k) number is K182467.

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

Simplexa GBS Direct, Simplexa GBS Positive Control Pack received FDA 510(k) clearance on 2018-11-07, under approval number K182467.

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

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

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

The FDA product code for Simplexa GBS Direct, Simplexa GBS Positive Control Pack is NJR.

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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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