Alinity m HBV

FDA Premarket Approval P200013 S004

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

DeviceAlinity m HBV
Generic NameHepatitis Viral B Dna Detection
ApplicantAbbott Molecular, Inc.
Date Received2021-02-05
Decision Date2021-03-08
PMAP200013
SupplementS004
Product CodeMKT 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Abbott Molecular, Inc. 1300 E Touhy Ave des Plaines, IL 60018

Supplemental Filings

Supplement NumberDateSupplement Type
P200013Original Filing
S004 2021-02-05 30-day Notice
S003 2021-02-05 30-day Notice
S002
S001 2020-12-21 30-day Notice

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