Alinity m HBV

FDA Premarket Approval P200013 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

The request to release the software version 1. 6. 2 in the united states, incorporating into the alinity m system software version 1. 6. 0, version 1. 6. 1 and 1. 6. 2, which are currently released outside the us, is approved.

DeviceAlinity m HBV
Generic NameHepatitis Viral B Dna Detection
ApplicantAbbott Molecular, Inc.
Date Received2021-04-15
Decision Date2021-06-01
PMAP200013
SupplementS005
Product CodeMKT 
Advisory CommitteeMicrobiology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
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
S005 2021-04-15 Real-time Process
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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