TANDEM-R PSA IMMUNORADIOMETRIC ASSAY

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

FDA Premarket Approval P850048

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

• Device: TANDEM-R PSA IMMUNORADIOMETRIC ASSAY
• 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: BECKMAN COULTER, INC.
• Date Received: 1985-07-09
• Decision Date: 1986-02-25
• Notice Date: 1986-04-09
• PMA: P850048
• Supplement: S
• Product Code: MTF
• Docket Number: 86M-0137
• Advisory Committee: Immunology
• Expedited Review: No
• Combination Product: No
• Applicant Address: BECKMAN COULTER, INC. 250 South Kraemer Blvd M/s w-110 brea, CA 92822

Supplemental Filings

Supplement Number	Date	Supplement Type
P850048		Original Filing
S058	2022-02-04	30-day Notice
S057
S056	2020-09-30	Real-time Process
S055	2020-07-22	Real-time Process
S054	2020-06-23	Real-time Process
S053	2019-12-18	Real-time Process
S052	2019-05-13	Real-time Process
S051	2019-05-02	Real-time Process
S050
S049	2018-09-25	Real-time Process
S048	2017-09-28	30-day Notice
S047
S046	2017-06-09	30-day Notice
S045	2017-03-22	Real-time Process
S044	2017-01-17	30-day Notice
S043	2016-10-11	30-day Notice
S042	2016-07-28	30-day Notice
S041	2015-05-07	Real-time Process
S040	2014-11-04	135 Review Track For 30-day Notice
S039	2014-08-25	Real-time Process
S038	2014-08-25	135 Review Track For 30-day Notice
S037	2013-12-17	Real-time Process
S036	2013-09-26	Special (immediate Track)
S035	2013-06-13	Special (immediate Track)
S034	2013-04-12	Special (immediate Track)
S033	2013-03-29	Real-time Process
S032	2013-01-23	Real-time Process
S031	2013-01-03	30-day Notice
S030
S029
S028	2012-10-25	Special (immediate Track)
S027	2012-03-15	Special (immediate Track)
S026	2011-12-23	Real-time Process
S025	2011-01-12	Special (immediate Track)
S024	2011-01-10	Special (immediate Track)
S023	2007-12-19	Real-time Process
S022	2007-05-16	Normal 180 Day Track
S021	2007-08-21	Panel Track
S020	2006-04-10	Real-time Process
S019	2002-12-20	Real-time Process
S018	2002-10-04	Real-time Process
S017	2002-08-19	Normal 180 Day Track
S016	1999-10-18	Normal 180 Day Track
S015	1999-07-12	30-day Notice
S014	1999-05-19	Normal 180 Day Track
S013	1999-04-27	Normal 180 Day Track
S012	1995-10-27	Normal 180 Day Track
S011	1995-06-14	Special (immediate Track)
S010
S009	1992-06-29	Panel Track
S008	1991-12-16	Normal 180 Day Track
S007	1991-07-01	Normal 180 Day Track
S006	1990-10-02	Normal 180 Day Track
S005	1990-02-07	Normal 180 Day Track
S004	1989-03-27	Normal 180 Day Track
S003	1989-03-02	Normal 180 Day Track
S002	1987-02-24	Normal 180 Day Track
S001	1987-02-24	Normal 180 Day Track