510(k) Premarket Notification

• 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
• Contact: robert s dicheck
• Regulation Number: 864.7280
• Classification Product Code: NPQ
• Subsequent Product Codes: NPR NSU OMM
• Date Received: 12/23/2009
• Decision Date: 04/22/2010
• Decision: substantially equivalent - CLIA submission (CS)
• Classification Advisory Committee: Hematology
• Review Advisory Committee: Hematology
• statement: statement
• FDA Review: Decision Summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No