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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 K060564
Device Name INFINITI SYSTEM
Applicant
AUTOGENOMICS, INC
2251 RUTHERFORD ROAD
carlsbad,  CA  92008
Applicant Contact evelyn lopez
Correspondent
AUTOGENOMICS, INC
2251 RUTHERFORD ROAD
carlsbad,  CA  92008
Correspondent Contact evelyn lopez
Regulation Number864.7280
Classification Product Code
NPQ  
Subsequent Product Codes
NPR   NSU  
Date Received03/03/2006
Decision Date 02/07/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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