FDA 510(k)

Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack

K-Number: K163085 · 2017-02-14

ApplicantFocus Diagnostics, Inc.:Dba Diasorin Molecular, LLC

Decision Date2017-02-14

Product CodeOZN

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack is a medical device manufactured by Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC. It received FDA 510(k) clearance on 2017-02-14 under approval number K163085. The device is classified under product code OZN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack?

Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack is a medical device that received FDA 510(k) clearance on 2017-02-14. It is manufactured by Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC. The 510(k) number is K163085.

When was Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack approved by the FDA?

Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack received FDA 510(k) clearance on 2017-02-14, under approval number K163085.

What company makes Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack?

Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack is manufactured by Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC.

What is the FDA product code for Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack?

The FDA product code for Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack is OZN.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.