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FDA 510(k)

SporView Rapid Read Biological Indicator SteamPlus Test Pack

K-Number: K181434 · 2018-11-14

ApplicantCrosstex/Spsmedical, A Division of Cantel Medical
Decision Date2018-11-14
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SporView Rapid Read Biological Indicator SteamPlus Test Pack is a medical device manufactured by Crosstex/Spsmedical, A Division of Cantel Medical. It received FDA 510(k) clearance on 2018-11-14 under approval number K181434. 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 SporView Rapid Read Biological Indicator SteamPlus Test Pack?

SporView Rapid Read Biological Indicator SteamPlus Test Pack is a medical device that received FDA 510(k) clearance on 2018-11-14. It is manufactured by Crosstex/Spsmedical, A Division of Cantel Medical. The 510(k) number is K181434.

When was SporView Rapid Read Biological Indicator SteamPlus Test Pack approved by the FDA?

SporView Rapid Read Biological Indicator SteamPlus Test Pack received FDA 510(k) clearance on 2018-11-14, under approval number K181434.

What company makes SporView Rapid Read Biological Indicator SteamPlus Test Pack?

SporView Rapid Read Biological Indicator SteamPlus Test Pack is manufactured by Crosstex/Spsmedical, A Division of Cantel Medical.

What is the FDA product code for SporView Rapid Read Biological Indicator SteamPlus Test Pack?

The FDA product code for SporView Rapid Read Biological Indicator SteamPlus Test Pack is FRC.

Related Clinical Trials

NCT03031587 Validation of Thermometric Cardiac Imaging by MRI COMPLETED

Other Devices by Crosstex/Spsmedical, A Division of Cantel Medical

K172432SporView Rapid Read Biological Indicator

Related Devices (Code: FRC)

K1605463M Attest Rapid Readout Biological Indicator3M Company K151482BCR-30-min BI™ and RBIP-ST30™ Readout AccessoryBcr Diagnostics, Inc. K172474Celerity 20 HP Biological IndicatorSTERIS Corporation K172432SporView Rapid Read Biological IndicatorCrosstex/Spsmedical, A Division of Cantel Medical K163646Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader IncubatorTerragene S.A. K170427Anprolene SteriTestAndersen Sterilizers, Inc.

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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