IMMULITE, IMMULITE 1000, IMMULITE 2000, and IMMULITE 2500 AFP

FDA Premarket Approval P010007 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

To remove select inspection criteria from the raw materials used to manufacture immulite substrate reagent

DeviceIMMULITE, IMMULITE 1000, IMMULITE 2000, and IMMULITE 2500 AFP
Generic NameKit, Test, Alpha-fetoprotein For Neural Tube Defects
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
Date Received2020-08-12
Decision Date2020-09-08
PMAP010007
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. 511 Benedict Ave. tarrytown, NY 10591

Supplemental Filings

Supplement NumberDateSupplement Type
P010007Original Filing
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
00630414953519 P010007 001
00630414963594 P010007 001
00630414953519 P010007 001
00630414961033 P010007 001
00630414961040 P010007 001
00630414963594 P010007 001
00630414953519 P010007 001
00630414961033 P010007 001
00630414961040 P010007 001
00630414963594 P010007 001
00630414953519 P010007 001
00630414961033 P010007 001
00630414961040 P010007 001
00630414961040 P010007 001
00630414961033 P010007 001
00630414961033 P010007 001
00630414961040 P010007 001
00630414963594 P010007 001
00630414953519 P010007 001
00630414961033 P010007 001
00630414961040 P010007 001
00630414963594 P010007 001
00630414953519 P010007 001
00630414961033 P010007 001
00630414961040 P010007 001
00630414963594 P010007 001
00630414953519 P010007 001
00630414963594 P010007 001
00630414953519 P010007 001
00630414963594 P010007 001
00630414953519 P010007 001
00630414961033 P010007 001
00630414961040 P010007 001
00630414963594 P010007 001
00630414953519 P010007 001
00630414961033 P010007 001
00630414961040 P010007 001
00630414963594 P010007 001
00630414953519 P010007 001
00630414961033 P010007 001
00630414961040 P010007 001
00630414961040 P010007 001
00630414961033 P010007 001
00630414961033 P010007 001
00630414961040 P010007 001
00630414963594 P010007 001
00630414953519 P010007 001
00630414961033 P010007 001
00630414961040 P010007 001
00630414963594 P010007 001
00630414953519 P010007 001
00630414961033 P010007 001
00630414961040 P010007 001
00630414963594 P010007 001
00630414953519 P010007 001
00630414963594 P010007 001

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