Immulite psa, immulite. Third generation psa, immulite 2000 psa, and immulite 2000 third generation psa. Immulite. Psa is indicated for in vitro diagnostic use with the immulite analyzer for the quantitative measurement of prostate-specific antigen (psa) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (dre) in men aged 50 years or older. Immulite third generation psa is indicated for in vitro diagnostic use with the immulite analyzer for the quantitative measurement of prostate-specific antigen (psa) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (dre) in men aged 50 years or older. Immulite 2000 psa is indicated for in vitro diagnostic use with the immulite 2000 analyzer for the quantitative measurement of prostate-specific antigen (psa) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (dre) in men aged 50 years or older. Immulite 2000 third generation psa is indicated for in vitro diagnostic use with the immulite 2000 analyzer for the quantitative measurement of prostate-specific antigen (psa) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (dre) in men aged 50 years of older.
| Device | IMMULITE(R)PSA, IMMULITE(R) THIRD GENERATION PSA, IMMULITE(R) 2000 |
| Classification Name | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Generic Name | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Date Received | 2001-01-02 |
| Decision Date | 2001-06-19 |
| Notice Date | 2001-12-05 |
| PMA | P930027 |
| Supplement | S004 |
| Product Code | LTJ |
| Docket Number | 01M-0535 |
| Advisory Committee | Immunology |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SIEMENS HEALTHCARE DIAGNOSTICS INC. glyn Rhonwy, Llanberis gwynedd Ll55 4el LL554 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| 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