FDA 510(k)

VERIFY Assert Self-Contained Biological Indicator

K-Number: K200126 · 2020-05-22

Decision Date2020-05-22

Product CodeFRC

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

VERIFY Assert Self-Contained Biological Indicator is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2020-05-22 under approval number K200126. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERIFY Assert Self-Contained Biological Indicator?

VERIFY Assert Self-Contained Biological Indicator is a medical device that received FDA 510(k) clearance on 2020-05-22. It is manufactured by STERIS Corporation. The 510(k) number is K200126.

When was VERIFY Assert Self-Contained Biological Indicator approved by the FDA?

VERIFY Assert Self-Contained Biological Indicator received FDA 510(k) clearance on 2020-05-22, under approval number K200126.

What company makes VERIFY Assert Self-Contained Biological Indicator?

VERIFY Assert Self-Contained Biological Indicator is manufactured by STERIS Corporation.

What is the FDA product code for VERIFY Assert Self-Contained Biological Indicator?

The FDA product code for VERIFY Assert Self-Contained Biological Indicator is FRC.

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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.