K-number	K151482
Device name	BCR-30-min BI and RBIP-ST30 Readout Accessory
Applicant	Bcr Diagnostics, Inc.
Product code	FRC
Device class	Class II
Decision date	Feb 26, 2016
Decision	Substantially Equivalent
Regulation	880.2800

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Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.

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