510(k) DEN040011
DEN040011 is an FDA 510(k) premarket notification submitted by Roche Molecular Systems, Inc. for the device "AMPLICHIP CYP450 TEST, MODEL 04381866190". The FDA issued a decision of De Novo Granted on December 23, 2004. The device falls under product code NTI (Drug Metabolizing Enzyme Genotyping Systems), a Class II device regulated under 21 CFR 862.3360. Roche Molecular Systems, Inc. has at least 10 other 510(k) clearances on record.
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.