ELECSYS HBEAG

Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)

FDA Premarket Approval P130015 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

Relocation of raw material production from one building to another within the same manufacturing site.

DeviceELECSYS HBEAG
Classification NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantROCHE DIAGNOSTICS OPERATIONS INC
Date Received2016-10-26
Decision Date2016-11-22
PMAP130015
SupplementS008
Product CodeLOM
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ROCHE DIAGNOSTICS OPERATIONS INC 9115 Hague Rd indianapolis, IN 46250

Supplemental Filings

Supplement NumberDateSupplement Type
P130015Original Filing
S016 2018-10-09 30-day Notice
S015 2018-04-17 Real-time Process
S014 2017-10-11 Real-time Process
S013 2017-09-15 Normal 180 Day Track
S012 2017-08-03 30-day Notice
S011 2017-07-18 30-day Notice
S010 2017-05-24 30-day Notice
S009 2016-12-20 Normal 180 Day Track No User Fee
S008 2016-10-26 30-day Notice
S007 2016-04-28 Normal 180 Day Track
S006 2016-02-16 30-day Notice
S005 2016-01-27 135 Review Track For 30-day Notice
S004 2015-10-07 30-day Notice
S003 2015-06-29 30-day Notice
S002 2014-10-16 Real-time Process
S001 2014-05-23 30-day Notice

NIH GUDID Devices

Device IDPMASupp
04015630935215 P130015 000
04015630934843 P130015 009

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