BCR-30-min BI and RBIP-ST30 Readout Accessory— 510(k) K151482

Substantially Equivalent

Bcr Diagnostics, Inc.

FDA 510(k) clearance K151482 for BCR-30-min BI and RBIP-ST30 Readout Accessory, Substantially Equivalent on 2016-02-26. Applicant: Bcr Diagnostics, Inc..

Clearance details

Applicant: Bcr Diagnostics, Inc.
Product code: Code FRC
Advisory panel: General Hospital
Date received: 2015-06-02
Decision date: 2016-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenix, AZ, US

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