FDA 510(k) Applications Submitted by JANET M FOSE

FDA 510(k) Number Submission Date Device Name Applicant
K090236 02/02/2009 DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454 SIEMENS HEALTHCARE DIAGNOSTICS
K102779 09/24/2010 EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C Siemens Healthcare Diagnostics Inc.
K083159 10/27/2008 BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2 SIEMENS HEALTHCARE DIAGNOSTICS
K083175 10/28/2008 BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2 SIEMENS HEALTHCARE DIAGNOSTICS


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