IMMULITE, IMMULITE 1000, IMMULITE 2000, and IMMULITE 2500 fPSA

FDA Premarket Approval P060005 S012

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 fPSA
Generic NameTest, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
ApplicantSIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED
Date Received2020-08-12
Decision Date2020-09-08
PMAP060005
SupplementS012
Product CodeMTG 
Advisory CommitteeImmunology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED glyn Rhonwy. Llanberis caernarfon gwynedd, Ll55 4EL

Supplemental Filings

Supplement NumberDateSupplement Type
P060005Original Filing
S012 2020-08-12 30-day Notice
S011 2020-07-23 30-day Notice
S010 2019-11-25 30-day Notice
S009 2018-09-28 Real-time Process
S008 2012-05-30 135 Review Track For 30-day Notice
S007 2011-12-19 135 Review Track For 30-day Notice
S006 2011-08-16 30-day Notice
S005 2011-08-08 30-day Notice
S004 2011-02-18 Real-time Process
S003 2009-11-02 Normal 180 Day Track No User Fee
S002
S001 2008-11-10 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
00630414977478 P060005 001
00630414977478 P060005 001
00630414977478 P060005 001
00630414977478 P060005 001
00630414977478 P060005 001
00630414977478 P060005 001
00630414977478 P060005 001
00630414977478 P060005 001
00630414977478 P060005 001
00630414977478 P060005 001
00630414977478 P060005 001
00630414977478 P060005 001
00630414977478 P060005 001
00630414971575 P060005 001
00630414971575 P060005 001
00630414971575 P060005 001
00630414971575 P060005 001
00630414977478 P060005 001
00630414971575 P060005 001
00630414971575 P060005 001
00630414971575 P060005 001
00630414971575 P060005 001
00630414971575 P060005 001
00630414971575 P060005 001
00630414971575 P060005 001
00630414971575 P060005 001
00630414971575 P060005 001
00630414971575 P060005 001
00630414977478 P060005 001

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