INFINITI CYP2C19 ASSAY

Drug Metabolizing Enzyme Genotyping Systems

AUTOGENOMICS, INCORPORATED

The following data is part of a premarket notification filed by Autogenomics, Incorporated with the FDA for Infiniti Cyp2c19 Assay.

Pre-market Notification Details

Device IDK101683
510k NumberK101683
Device Name:INFINITI CYP2C19 ASSAY
ClassificationDrug Metabolizing Enzyme Genotyping Systems
Applicant AUTOGENOMICS, INCORPORATED 2980 SCOTT STREET Vista,  CA  92081
ContactEvelyn G Lopez
CorrespondentEvelyn G Lopez
AUTOGENOMICS, INCORPORATED 2980 SCOTT STREET Vista,  CA  92081
Product CodeNTI  
CFR Regulation Number862.3360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-06-15
Decision Date2010-10-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850009370150 K101683 000
00850009370143 K101683 000
00850009370136 K101683 000

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