ELECSYS ANTI-HCV ON MODULAR ANALYTICS E170

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Premarket Approval P090009 S007

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

Approval for a transfer of a portion of the manufacturing operations for the bulk solutions of reagents r1 and r2, as well as bulk solutions of pretreatment reagents to newly constructed manufacturing space.

DeviceELECSYS ANTI-HCV ON MODULAR ANALYTICS E170
Classification NameAssay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Generic NameAssay, Enzyme Linked Immunosorbent, Hepatitis C Virus
ApplicantROCHE DIAGNOSTICS CORP.
Date Received2012-01-31
Decision Date2012-12-20
PMAP090009
SupplementS007
Product CodeMZO
Advisory CommitteeMicrobiology
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ROCHE DIAGNOSTICS CORP. 9115 Hague Rd. indianapolis, IN 46250

Supplemental Filings

Supplement NumberDateSupplement Type
P090009Original Filing
S018 2018-10-26 Normal 180 Day Track No User Fee
S017 2017-10-11 Real-time Process
S016 2017-08-03 30-day Notice
S015 2016-02-16 30-day Notice
S014 2016-01-27 30-day Notice
S013 2015-10-07 30-day Notice
S012 2014-08-22 30-day Notice
S011 2012-11-30 30-day Notice
S010 2012-09-05 30-day Notice
S009
S008 2012-02-29 30-day Notice
S007 2012-01-31 135 Review Track For 30-day Notice
S006 2011-11-21 30-day Notice
S005 2011-08-29 135 Review Track For 30-day Notice
S004 2011-08-17 135 Review Track For 30-day Notice
S003 2011-05-17 Normal 180 Day Track No User Fee
S002 2011-04-11 30-day Notice
S001 2010-07-28 Normal 180 Day Track

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