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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name test, factor v leiden mutations, genomic dna pcr
510(k) Number K093974
Device Name ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING
Applicant
OSMETECH MOLECULAR DIAGNOSTICS
757 SOUTH RAYMOND AVE.
pasadena,  CA  91105
Applicant Contact robert s dicheck
Correspondent
OSMETECH MOLECULAR DIAGNOSTICS
757 SOUTH RAYMOND AVE.
pasadena,  CA  91105
Correspondent Contact robert s dicheck
Regulation Number864.7280
Classification Product Code
NPQ  
Subsequent Product Codes
NPR   NSU   OMM  
Date Received12/23/2009
Decision Date 04/22/2010
Decision substantially equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
statement statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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