IMMUNOASAY, PSA

Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Premarket Approval P910065 S008

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

Approval for the addition of one fda-cleared tosoh automated immunoassay analyzer, the aia-900, for use with the st aia-pack pa assay.

DeviceIMMUNOASAY, PSA
Classification NameTotal, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer
Generic NameTotal, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer
ApplicantTOSOH BIOSCIENCE, INC.
Date Received2011-03-30
Decision Date2012-02-13
PMAP910065
SupplementS008
Product CodeMTF
Advisory CommitteeImmunology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address TOSOH BIOSCIENCE, INC. 6000 Shoreline Court suite 101 south San Francisco, CA 94080

Supplemental Filings

Supplement NumberDateSupplement Type
P910065Original Filing
S009 2019-05-20 Special (immediate Track)
S008 2011-03-30 Normal 180 Day Track
S007 2009-04-24 Normal 180 Day Track
S006 2005-06-06 Normal 180 Day Track
S005 2004-04-07 Normal 180 Day Track
S004 2003-06-04 Normal 180 Day Track
S003 2002-01-09 Normal 180 Day Track
S002 1999-12-16 Normal 180 Day Track
S001 1999-03-25 Panel Track

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