BIO-RAD MONOLISA ANTI-HBC EIA

FDA Premarket Approval P060031 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

Change to add test samples as an additional acceptance criterion to the final kit release quality control testing procedure.

DeviceBIO-RAD MONOLISA ANTI-HBC EIA
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantBio-Rad Laboratories, Inc.
Date Received2013-11-13
Decision Date2013-12-12
PMAP060031
SupplementS007
Product CodeLOM 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Bio-Rad Laboratories, Inc. 6565 185th Ave., N.e. redmond, WA 98052

Supplemental Filings

Supplement NumberDateSupplement Type
P060031Original Filing
S007 2013-11-13 30-day Notice
S006 2012-10-19 30-day Notice
S005 2011-03-31 30-day Notice
S004 2010-06-17 Normal 180 Day Track No User Fee
S003 2009-09-28 Normal 180 Day Track
S002 2009-02-12 Special (immediate Track)
S001 2008-09-22 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00847865013116 P060031 000
00847865013109 P060031 000
00847865013093 P060031 000
00847865013086 P060031 000
00847865013079 P060031 000
00847865011372 P060031 000

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