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

FDA 510(k)

BCR-30-min BI™ and RBIP-ST30™ Readout Accessory

K-Number: K151482 · 2016-02-26

ApplicantBcr Diagnostics, Inc.
Decision Date2016-02-26
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BCR-30-min BI™ and RBIP-ST30™ Readout Accessory is a medical device manufactured by Bcr Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-02-26 under approval number K151482. 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 BCR-30-min BI™ and RBIP-ST30™ Readout Accessory?

BCR-30-min BI™ and RBIP-ST30™ Readout Accessory is a medical device that received FDA 510(k) clearance on 2016-02-26. It is manufactured by Bcr Diagnostics, Inc.. The 510(k) number is K151482.

When was BCR-30-min BI™ and RBIP-ST30™ Readout Accessory approved by the FDA?

BCR-30-min BI™ and RBIP-ST30™ Readout Accessory received FDA 510(k) clearance on 2016-02-26, under approval number K151482.

What company makes BCR-30-min BI™ and RBIP-ST30™ Readout Accessory?

BCR-30-min BI™ and RBIP-ST30™ Readout Accessory is manufactured by Bcr Diagnostics, Inc..

What is the FDA product code for BCR-30-min BI™ and RBIP-ST30™ Readout Accessory?

The FDA product code for BCR-30-min BI™ and RBIP-ST30™ Readout Accessory is FRC.

Related Devices (Code: FRC)

K1605463M Attest Rapid Readout Biological Indicator3M Company 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. K171504VERIFY Assert VH2O2 Self-Contained Biological IndicatorSTERIS 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.

↑