IMMULITE SYSTEMS PSA & THIRD GENERATION PSA REAGENTS

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

FDA Premarket Approval P930027

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the coat-a-count psa irma

• Device: IMMULITE SYSTEMS PSA & THIRD GENERATION PSA REAGENTS
• Classification Name: Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer
• Generic Name: Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer
• Applicant: SIEMENS HEALTHCARE DIAGNOSTICS INC.
• Date Received: 1993-08-10
• Decision Date: 1995-09-15
• Notice Date: 1996-09-12
• PMA: P930027
• Supplement: S
• Product Code: MTF
• Docket Number: 96M-0217
• Advisory Committee: Immunology
• Expedited Review: No
• Combination Product: No
• Applicant Address: SIEMENS HEALTHCARE DIAGNOSTICS INC. glyn Rhonwy, Llanberis gwynedd Ll55 4el LL554
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P930027		Original Filing
S028	2022-09-15	30-day Notice
S027
S026	2022-02-28	30-day Notice
S025	2021-04-14	30-day Notice
S024	2020-08-12	30-day Notice
S023	2020-07-23	30-day Notice
S022	2019-11-25	30-day Notice
S021	2019-06-19	Special (immediate Track)
S020	2018-09-28	Real-time Process
S019	2018-03-19	Special (immediate Track)
S018	2017-09-15	Special (immediate Track)
S017	2016-08-17	135 Review Track For 30-day Notice
S016	2014-07-23	135 Review Track For 30-day Notice
S015	2012-05-30	135 Review Track For 30-day Notice
S014	2011-12-19	135 Review Track For 30-day Notice
S013	2011-08-16	30-day Notice
S012	2011-08-08	30-day Notice
S011	2011-02-18	Real-time Process
S010	2009-11-02	Normal 180 Day Track No User Fee
S009
S008	2008-12-16	Normal 180 Day Track
S007	2008-11-10	Normal 180 Day Track No User Fee
S006	2003-11-28	Real-time Process
S005	2003-01-21	Real-time Process
S004	2001-01-02	Panel Track
S003	1998-02-20	Normal 180 Day Track
S002
S001	1995-10-18	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
00630414954196	P930027	001
00630414982267	P930027	003
00630414982229	P930027	003
00630414982212	P930027	003
00630414982205	P930027	003
00630414982281	P930027	004