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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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