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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name drug metabolizing enzyme genotyping systems
510(k) Number K123891
Device Name SPARTAN RX CYP2C19 TEST SYSTEM
Applicant
SPARTAN BIOSCIENCE INC
3 LAGOON DRIVE, STE 280
redwood shores,  CA  94065
Applicant Contact lorry huffman
Correspondent
SPARTAN BIOSCIENCE INC
3 LAGOON DRIVE, STE 280
redwood shores,  CA  94065
Correspondent Contact lorry huffman
Regulation Number862.3360
Classification Product Code
NTI  
Subsequent Product Code
NSU  
Date Received12/18/2012
Decision Date 08/12/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
summary summary
FDA Review Decision Summary
Type Abbreviated
Clinical Trials NCT01676298
NCT01718535
Reviewed by Third Party No
Combination Product No
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