Abbott RealTime IDH1 Assay

Somatic Gene Mutation Detection System

FDA Premarket Approval P170041 S002

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for update of quality procedures for amplification reagent kit and control kit

DeviceAbbott RealTime IDH1 Assay
Classification NameSomatic Gene Mutation Detection System
Generic NameSomatic Gene Mutation Detection System
ApplicantAbbott Molecular, Inc.
Date Received2019-10-16
Decision Date2019-11-12
PMAP170041
SupplementS002
Product CodeOWD
Advisory CommitteeMolecular Genetics
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Abbott Molecular, Inc. 1300 East Touhy Avenue des Plaines, IL 60018

Supplemental Filings

Supplement NumberDateSupplement Type
P170041Original Filing
S002 2019-10-16 30-day Notice
S001 2019-08-29 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00884999047792 P170041 000
00884999047358 P170041 000
00884999047341 P170041 000

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