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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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