FDA 510(k) Applications Submitted by CLARE SANTULLI

FDA 510(k) Number Submission Date Device Name Applicant
K090257 02/02/2009 IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT SIEMENS HEALTHCARE DIAGNOSTICS
K140609 03/10/2014 RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS COVIDIEN
K140941 04/14/2014 PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH SOFRADIM PRODUCTION
K091123 04/17/2009 ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS SIEMENS HEALTHCARE DIAGNOSTICS
K091289 05/01/2009 IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT SIEMENS HEALTHCARE DIAGNOSTICS
K101572 06/04/2010 IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT SIEMENS HEALTHCARE DIAGNOSTICS
K171770 06/14/2017 cobas Cdiff Nucleic acid test for use on the cobas Liat System Roche Molecular Systems, Inc.
K091867 06/23/2009 ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773 SIEMENS HEALTHCARE DIAGNOSTICS
K131969 06/28/2013 SYMBOTEX(TM) COMPOSITE MESH SOFRADIM PRODUCTION
K091984 07/02/2009 IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
K092993 09/28/2009 ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL SIEMENS HEALTHCARE DIAGNOSTICS
K152794 09/28/2015 Cytosponge Cell Collection Device Covidien LLC
K093107 10/01/2009 IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT SIEMENS HEALTHCARE DIAGNOSTICS
K102904 10/01/2010 ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL SIEMENS HEALTHCARE DIAGNOSTICS
K083314 11/10/2008 IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT SIEMENS HEALTHCARE DIAGNOSTICS
K083853 12/24/2008 IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT SIEMENS HEALTHCARE DIAGNOSTICS


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