Alinity m HBV

FDA Premarket Approval P200013 S008

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
Generic NameHepatitis Viral B Dna Detection
ApplicantAbbott Molecular, Inc.1300 E Touhy Avedes Plaines, IL 60018 PMA NumberP200013 Supplement NumberS008 Date Received05/10/2022 Decision Date06/08/2022 Product Code MKT  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-05-10
Decision Date2022-06-08
PMAP200013
SupplementS008
Product CodeMKT 
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 NumberS008 Date Received05/10/2022 Decision Date06/08/2022 Product Code MKT  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
use Of An Alternate Component In A Septum Cap Assembly Since The Current Material Is No Longer Available.

Supplemental Filings

Supplement NumberDateSupplement Type
P200013Original Filing
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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