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510(k) K101683

INFINITI CYP2C19 ASSAY by Autogenomics, Incorporated — Product Code NTI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2010
Date Received
June 15, 2010
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drug Metabolizing Enzyme Genotyping Systems
Device Class
Class II
Regulation Number
862.3360
Review Panel
TX
Submission Type

Intended to identify the presence or absence of human genotypic markers encoding drug metaboizing enzymes using dna originating from clinical samples. This type of assay can be used as an aid determining treatment choice and individualizing treatment dose for therapeutics that are metabolized primarily by the specific enzyme tested by the system.

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