cobas HCV

FDA Premarket Approval P150015 S037

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 of a supplier's manufacturing site for a critical component

Devicecobas HCV
Generic NameAssay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus
ApplicantRoche Molecular Systems, Inc.
Date Received2020-01-10
Decision Date2020-02-06
PMAP150015
SupplementS037
Product CodeMZP 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Roche Molecular Systems, Inc. 4300 Hacienda Drive pleasanton, CA 94588-2722

Supplemental Filings

Supplement NumberDateSupplement Type
P150015Original Filing
S037 2020-01-10 30-day Notice
S036 2019-11-29 30-day Notice
S035 2019-09-20 30-day Notice
S034 2019-08-30 30-day Notice
S033 2019-08-06 30-day Notice
S032
S031 2019-05-09 30-day Notice
S030 2019-05-09 30-day Notice
S029 2019-04-24 30-day Notice
S028 2019-04-24 30-day Notice
S027 2019-04-10 30-day Notice
S026 2019-04-08 30-day Notice
S025 2019-04-03 30-day Notice
S024 2019-03-27 30-day Notice
S023 2018-12-14 30-day Notice
S022 2018-11-13 30-day Notice
S021 2018-11-09 30-day Notice
S020 2018-08-21 30-day Notice
S019
S018 2018-07-27 30-day Notice
S017 2018-06-29 30-day Notice
S016 2018-06-08 30-day Notice
S015 2018-06-04 30-day Notice
S014 2018-04-16 30-day Notice
S013 2018-03-01 30-day Notice
S012 2018-01-23 30-day Notice
S011 2017-11-22 30-day Notice
S010 2017-10-30 30-day Notice
S009 2017-09-27 30-day Notice
S008 2017-09-26 30-day Notice
S007 2017-07-14 30-day Notice
S006 2017-05-09 30-day Notice
S005 2016-11-22 Special (immediate Track)
S004 2016-08-08 Real-time Process
S003 2016-07-08 30-day Notice
S002 2016-04-07 30-day Notice
S001 2016-02-26 30-day Notice

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