FDA 510(k), K151482, BCR-30-min BI™ and RBIP-ST30™ Readout Accessory

FDA 510(k), K151482, BCR-30-min BI™ and RBIP-ST30™ Readout Accessory

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510(K) Number: K151482
Device Name: BCR-30-min BI™ and RBIP-ST30™ Readout Accessory
Manufacturer: BCR DIAGNOSTICS, INC.
Device Classification Name: indicator, biological sterilization process
Regulation Number: 880.2800
Classification Product Code: FRC
Date Received: 06/02/2015
Decision Date: 02/26/2016
Regulation Medical Specialty: General Hospital

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