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FDA 510(k)

SporView Rapid Read Biological Indicator

K-Number: K172432 · 2017-12-12

ApplicantCrosstex/Spsmedical, A Division of Cantel Medical
Decision Date2017-12-12
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SporView Rapid Read Biological Indicator is a medical device manufactured by Crosstex/Spsmedical, A Division of Cantel Medical. It received FDA 510(k) clearance on 2017-12-12 under approval number K172432. 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?

SporView Rapid Read Biological Indicator is a medical device that received FDA 510(k) clearance on 2017-12-12. It is manufactured by Crosstex/Spsmedical, A Division of Cantel Medical. The 510(k) number is K172432.

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

SporView Rapid Read Biological Indicator received FDA 510(k) clearance on 2017-12-12, under approval number K172432.

What company makes SporView Rapid Read Biological Indicator?

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

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

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

Related Clinical Trials

NCT03031587 Validation of Thermometric Cardiac Imaging by MRI COMPLETED

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

K181434SporView Rapid Read Biological Indicator SteamPlus Test Pack

Related Devices (Code: 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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