Elecsys Anti-HCV II

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Premarket Approval P140021 S016

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 manufacturing site for the cobas e 411 analyzer located at hitachi high-technologies corp. , 1892-1, oazategama, omuta, fukuoka, 836-0004 japan

DeviceElecsys Anti-HCV II
Classification NameAssay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Generic NameAssay, Enzyme Linked Immunosorbent, Hepatitis C Virus
ApplicantROCHE DIAGNOSTICS OPERATIONS INC
Date Received2018-10-26
Decision Date2019-04-24
PMAP140021
SupplementS016
Product CodeMZO
Advisory CommitteeMicrobiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ROCHE DIAGNOSTICS OPERATIONS INC 9115 Hague Road p.o. Box 50416 indianapolis, IN 46250-0416

Supplemental Filings

Supplement NumberDateSupplement Type
P140021Original Filing
S016 2018-10-26 Normal 180 Day Track No User Fee
S015 2018-10-09 30-day Notice
S014 2018-04-17 Real-time Process
S013 2018-03-01 Real-time Process
S012 2017-10-11 Real-time Process
S011 2017-08-03 30-day Notice
S010 2017-07-03 Normal 180 Day Track
S009 2017-05-24 30-day Notice
S008 2017-03-21 Normal 180 Day Track
S007 2016-09-30 Real-time Process
S006 2016-02-16 30-day Notice
S005 2016-01-29 Normal 180 Day Track
S004 2016-01-27 30-day Notice
S003 2016-01-27 135 Review Track For 30-day Notice
S002 2015-12-17 Normal 180 Day Track
S001 2015-10-07 30-day Notice

NIH GUDID Devices

Device IDPMASupp
04015630936670 P140021 008
04015630936663 P140021 008

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