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FDA 510(k) Applications Submitted by ROBERT S DICHECK
FDA 510(k) Number
Submission Date
Device Name
Applicant
K073720
12/31/2007
ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT
OSMETECH MOLECULAR DIAGNOSTICS
K090901
04/01/2009
ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8
OSMETECH MOLECULAR DIAGNOSTICS
K093974
12/23/2009
ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING
OSMETECH MOLECULAR DIAGNOSTICS
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