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FDA 510(k)

VERIFY Incubator for Assert Self Contained Biological Indicators

K-Number: K163587 · 2017-03-24

ApplicantSTERIS Corporation
Decision Date2017-03-24
Product CodeOWP
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VERIFY Incubator for Assert Self Contained Biological Indicators is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2017-03-24 under 510(k) number K163587. The device is classified under product code OWP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERIFY Incubator for Assert Self Contained Biological Indicators?

VERIFY Incubator for Assert Self Contained Biological Indicators is a medical device that received FDA 510(k) clearance on 2017-03-24. The listed applicant is STERIS Corporation. The 510(k) number is K163587.

When did VERIFY Incubator for Assert Self Contained Biological Indicators receive FDA 510(k) clearance?

VERIFY Incubator for Assert Self Contained Biological Indicators received FDA 510(k) clearance on 2017-03-24, under 510(k) number K163587.

Who is the listed applicant for VERIFY Incubator for Assert Self Contained Biological Indicators?

The FDA 510(k) record lists STERIS Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VERIFY Incubator for Assert Self Contained Biological Indicators?

The FDA product code for VERIFY Incubator for Assert Self Contained Biological Indicators is OWP.

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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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