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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
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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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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