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FDA 510(k)

CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack

K-Number: K183294 · 2019-01-03

ApplicantSTERIS Corporation
Decision Date2019-01-03
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2019-01-03 under approval number K183294. 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 CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack?

CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack is a medical device that received FDA 510(k) clearance on 2019-01-03. It is manufactured by STERIS Corporation. The 510(k) number is K183294.

When was CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack approved by the FDA?

CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack received FDA 510(k) clearance on 2019-01-03, under approval number K183294.

What company makes CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack?

CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack is manufactured by STERIS Corporation.

What is the FDA product code for CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack?

The FDA product code for CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack is FRC.

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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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