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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 the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2019-01-03 under 510(k) 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. The listed applicant is STERIS Corporation. The 510(k) number is K183294.

When did CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack receive FDA 510(k) clearance?

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

Who is the listed applicant for CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack?

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 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.

Other records listing STERIS Corporation as applicant

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Related Devices (Code: FRC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260766Celerity 5 HP Biological Indicator (LCB052)STERIS CorporationK252680Celerity™ 20 HP Biological IndicatorSTERIS CorporationK251122Terragene® Bionova® BT20 Biological IndicatorTerrageneK251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)SterisK250061Celerity IncubatorSTERIS CorporationK250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)STERIS Corporation

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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