FDA 510(k) Applications Submitted by Edward C. Brehm

FDA 510(k) Number Submission Date Device Name Applicant
K102700 09/20/2010 LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS ALERE, SAN DIEGO, DBA BIOSITE INCORPORATED, DBA IN
K120615 02/29/2012 ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE ALERE SAN DIEGO INC. DBA BIOSITE,INNOVACON,HEMOSEN
K171976 06/30/2017 Sofia Strep A+ FIA, Sofia 2 Analyzer Quidel Corporation
K153012 10/14/2015 Sofia Influenza A+B FIA QUIDEL CORPORATION
K162911 10/17/2016 Sofia RSV FIA on Sofia 2 analyzer Quidel Corporation


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