Abbott RealTime IDH1

FDA Premarket Approval P170041 S005

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

Addition of alternative testing location for a device component

DeviceAbbott RealTime IDH1
Generic NameSomatic Gene Mutation Detection System
ApplicantAbbott Molecular, Inc.
Date Received2021-02-05
Decision Date2021-03-03
PMAP170041
SupplementS005
Product CodeOWD 
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
S006 2021-12-17 Normal 180 Day Track
S005 2021-02-05 30-day Notice
S004
S003 2020-12-21 30-day Notice
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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