510(k) DEN040011

AMPLICHIP CYP450 TEST, MODEL 04381866190 by Roche Molecular Systems, Inc. — Product Code NTI

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: December 23, 2004
Date Received: December 20, 2004
Clearance Type: Post-NSE
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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