Alinity m HBV Assay

FDA Premarket Approval P200013 S012

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

DeviceAlinity m HBV Assay
ApplicantAbbott Molecular, Inc.1300 E Touhy Avedes Plaines, IL 60018 PMA NumberP200013 Supplement NumberS012 Date Received12/20/2022 Decision Date01/13/2023 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-12-20
Decision Date2023-01-13
PMAP200013
SupplementS012
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressAbbott Molecular, Inc.
1300 E Touhy Ave
des Plaines, IL 60018 PMA NumberP200013 Supplement NumberS012 Date Received12/20/2022 Decision Date01/13/2023 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
a Supplier Site Relocation With Process Changes For A Critical Component

Supplemental Filings

Supplement NumberDateSupplement Type
P200013Original Filing
S012 2022-12-20 30-day Notice
S011 2022-12-07 Special (immediate Track)
S010
S009 2022-09-21 Special (immediate Track)
S008 2022-05-10 30-day Notice
S007
S006 2022-02-17 30-day Notice
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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