FDA 510(k) Applications for Medical Device Product Code "LTJ"
(Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K002376 | BAYER CORP. | ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY | 10/26/2000 |
| K994221 | BAYER CORP. | BAYER PSA ASSAY | 04/13/2000 |
| K022288 | BAYER CORP. | COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM | 12/17/2002 |
| K980376 | BAYER CORP. | THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | 04/23/1998 |
| K022177 | BAYER DIAGNOSTICS CORP. | PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | 12/17/2002 |
| K974816 | BECKMAN INSTRUMENTS, INC. | ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229 | 02/20/1998 |
| K964595 | BEHRING DIAGNOSTICS, INC. | OPUS PSA TEST SYSTEM | 06/24/1997 |
| K981634 | BIOCIRCUITS CORP. | BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS | 10/13/1998 |
| K010550 | BIOMERIEUX, INC. | VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428 | 04/24/2001 |
| K974189 | BOEHRINGER MANNHEIM CORP. | ELECSYS PSA (ON ELECSYS 1010) | 01/06/1998 |
| K964351 | BOEHRINGER MANNHEIM CORP. | ELECSYS PSA ASSAY | 07/25/1997 |
| K982948 | BOEHRINGER MANNHEIM CORP. | ELECSYS PSA, MODEL # ELECSYS 1010 | 10/27/1998 |
| K982949 | BOEHRINGER MANNHEIM CORP. | ELECSYS PSA, MODEL 2010 | 10/27/1998 |
| K965085 | BOEHRINGER MANNHEIM CORP. | ENZYMUN-TEST PSA | 03/19/1997 |
| K981839 | CHIRON DIAGNOSTICS CORP. | ACS:CENTAUR PSA2 IMMUNOASSAY | 08/12/1998 |
| K003963 | DADE BEHRING, INC. | DIMENSION PSA FLEX REAGENT CARTRIDGE | 02/28/2001 |
| K031343 | DADE BEHRING, INC. | TPSA FLEX REAGENT CARTRIDGE | 05/15/2003 |
| K973101 | DADE CHEMISTRY SYSTEMS, INC. | PROSTATE SPECIFIC ANTIGEN METHOD | 09/18/1997 |
| K974842 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE 2000 3RD GENERATION PSA | 04/21/1998 |
| K972095 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE 2000 PSA | 08/22/1997 |
| K972021 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5) | 10/31/1997 |
| K973243 | DIAGNOSTIC SYSTEMS LABORATORIES, INC. | ACTIVE PSA ELISA (DSL-10-9700) | 08/03/1998 |
| K973244 | DIAGNOSTIC SYSTEMS LABORATORIES, INC. | ACTIVE PSA IRMA (DSL-9700) | 08/03/1998 |
| K124056 | NANOEN TEK, INC. | FREND PSA PLUS (REAGENT CARTRIDGE) | 05/29/2013 |
| K162378 | NANOENTEK USA INC | FREND PSA PLUS (reagent cartridge) | 05/17/2017 |
| K980716 | NICHOLS INSTITUTE DIAGNOSTICS | ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY | 04/03/1998 |
| K002313 | ONCOGENE SCIENCE, INC. | COMPLEXED PSA MICROTITER ELISA | 08/30/2000 |
| K002121 | ONCOGENE SCIENCE, INC. | TOTAL PSA MICROTITER ELISA | 08/30/2000 |
| K000566 | Ortho-Clinical Diagnostics, Inc. | MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS | 03/09/2000 |
| K984289 | Ortho-Clinical Diagnostics, Inc. | VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK | 03/12/1999 |
| K003094 | Qualigen, Inc. | FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER | 10/25/2000 |
| K994419 | QUALISYS DIAGNOSTICS, INC. | FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM | 06/28/2000 |
| K990234 | QUALISYS DIAGNOSTICS, INC. | QUALISYS PSA IMMUNOASSAY | 07/08/1999 |
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