ELECSYS HBEAG AND PRECICONTROL HBEAG

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

FDA Premarket Approval P130015 S009

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 the change of proprietary names of elecsys hbeag immunoassay and elecsys precicontrol hbeag to elecsys hbeag and precicontrol hbeag.

DeviceELECSYS HBEAG AND PRECICONTROL 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 Received2016-12-20
Decision Date2017-01-13
PMAP130015
SupplementS009
Product CodeLOM
Advisory CommitteeMicrobiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Pas
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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