ABBOTT REALTIME HCV

Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus

FDA Premarket Approval P100017 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

Change to the configuration of the current label printer, label printing software, and label inspection system at the des plaines, illinois manufacturing site.

DeviceABBOTT REALTIME HCV
Classification NameAssay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus
Generic NameAssay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus
ApplicantABBOTT MOLECULAR, INC.
Date Received2013-02-04
Decision Date2013-03-01
PMAP100017
SupplementS004
Product CodeMZP
Advisory CommitteeMicrobiology
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
P100017Original Filing
S024 2021-02-05 30-day Notice
S023 2020-11-16 30-day Notice
S022 2019-04-10 30-day Notice
S021 2018-05-25 30-day Notice
S020 2017-06-27 135 Review Track For 30-day Notice
S019 2016-12-01 30-day Notice
S018 2016-06-01 30-day Notice
S017 2016-04-20 30-day Notice
S016 2016-03-28 30-day Notice
S015 2016-03-25 30-day Notice
S014 2015-07-29 Real-time Process
S013
S012 2015-03-26 30-day Notice
S011 2014-11-10 30-day Notice
S010 2014-10-24 30-day Notice
S009 2013-11-12 30-day Notice
S008 2013-10-21 30-day Notice
S007 2013-07-23 30-day Notice
S006 2013-05-01 30-day Notice
S005 2013-03-01 Normal 180 Day Track
S004 2013-02-04 30-day Notice
S003 2012-10-04 30-day Notice
S002 2012-04-02 135 Review Track For 30-day Notice
S001 2011-07-01 135 Review Track For 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00884999042681 P100017 014

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