IMMULITE/IMMULITE 1000 AFP

FDA Premarket Approval P010007 S014

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

Modify resin used in manufacture of test unit cap/body

DeviceIMMULITE/IMMULITE 1000 AFP
Generic NameKit, Test, Alpha-fetoprotein For Neural Tube Defects
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
Date Received2021-04-14
Decision Date2021-04-28
PMAP010007
SupplementS014
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. 511 Benedict Ave. tarrytown, NY 10591

Supplemental Filings

Supplement NumberDateSupplement Type
P010007Original Filing
S014 2021-04-14 30-day Notice
S013 2020-08-12 30-day Notice
S012 2020-07-23 30-day Notice
S011 2019-11-25 30-day Notice
S010 2018-09-28 Real-time Process
S009 2012-05-30 135 Review Track For 30-day Notice
S008 2011-12-19 135 Review Track For 30-day Notice
S007 2011-08-16 30-day Notice
S006 2011-08-08 30-day Notice
S005 2011-02-18 Real-time Process
S004 2009-11-02 Normal 180 Day Track No User Fee
S003
S002 2003-12-12 Real-time Process
S001 2003-01-21 Real-time Process

NIH GUDID Devices

Device IDPMASupp
00630414963594 P010007 001
00630414961040 P010007 001
00630414961033 P010007 001
00630414953519 P010007 001

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