Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK

K-Number: K073618 · 2009-01-07

ApplicantSTERIS Corporation
Decision Date2009-01-07
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VERIFY SIRIUS BIOLOGICAL INDICATOR 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 2009-01-07 under 510(k) number K073618. 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 SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK?

VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK is a medical device that received FDA 510(k) clearance on 2009-01-07. The listed applicant is STERIS Corporation. The 510(k) number is K073618.

When did VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK receive FDA 510(k) clearance?

VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK received FDA 510(k) clearance on 2009-01-07, under 510(k) number K073618.

Who is the listed applicant for VERIFY SIRIUS BIOLOGICAL INDICATOR 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 VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK?

The FDA product code for VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK is FRC.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing STERIS Corporation as applicant

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.

K261055AMSCO 700 Steam SterilizerK251666SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900K260766Celerity 5 HP Biological Indicator (LCB052)K252680Celerity™ 20 HP Biological IndicatorK251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118K243876VERIFY STEAM Integrating Indicator

View all 196 devices →

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.

↑