ADVIA Centaur and Atellica IM AFP

FDA Premarket Approval P930036 S013

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

Scale-up and implementation of a common mixing process for all kit bulk reagents.

DeviceADVIA Centaur and Atellica IM AFP
Generic NameKit, Test, Alpha-fetoprotein For Neural Tube Defects
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
Date Received2020-02-21
Decision Date2020-03-19
PMAP930036
SupplementS013
Product CodeLOK 
Advisory CommitteeImmunology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address SIEMENS HEALTHCARE DIAGNOSTICS INC. 333 Coney Street east Walpole, MA 02032

Supplemental Filings

Supplement NumberDateSupplement Type
P930036Original Filing
S013 2020-02-21 30-day Notice
S012
S011 2019-02-01 30-day Notice
S010 2018-12-06 Normal 180 Day Track
S009 2018-07-27 Real-time Process
S008 2017-09-01 Normal 180 Day Track
S007 2016-10-20 135 Review Track For 30-day Notice
S006 2015-07-17 Normal 180 Day Track
S005 2012-03-26 Normal 180 Day Track No User Fee
S004 2012-02-15 135 Review Track For 30-day Notice
S003 2005-07-22 Real-time Process
S002 2002-01-16 Real-time Process
S001 1998-05-01 Real-time Process

NIH GUDID Devices

Device IDPMASupp
00630414597720 P930036 001
00630414124797 P930036 001
00630414124933 P930036 001
00630414124940 P930036 001
00630414126319 P930036 001
00630414177328 P930036 001
00630414177335 P930036 001
00630414597720 P930036 001
00630414022963 P930036 001
00630414124797 P930036 001
00630414177335 P930036 001
00630414177328 P930036 001
00630414126319 P930036 001
00630414124940 P930036 001
00630414124933 P930036 001
00630414022963 P930036 001
00630414238791 P930036 008
00630414238807 P930036 008
00630414238791 P930036 008
00630414238807 P930036 008

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