| Atellica IM Total PSA II (tPSAII) (K251630) | Siemens Healthcare Diagnostics, Inc. | 2026-01-05 |
| FREND PSA PLUS (reagent cartridge) (K162378) | Nanoentek USA, Inc. | 2017-05-17 |
| FREND PSA PLUS (REAGENT CARTRIDGE) (K124056) | Nanoentek, Inc. | 2013-05-29 |
| TPSA FLEX REAGENT CARTRIDGE (K031343) | Dade Behring, Inc. | 2003-05-15 |
| PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K022177) | Bayer Diagnostics Corp. | 2002-12-17 |
| COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM (K022288) | Bayer Corp. | 2002-12-17 |
| VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428 (K010550) | bioMerieux, Inc. | 2001-04-24 |
| DIMENSION PSA FLEX REAGENT CARTRIDGE (K003963) | Dade Behring, Inc. | 2001-02-28 |
| ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY (K002376) | Bayer Corp. | 2000-10-26 |
| FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER (K003094) | Qualigen, Inc. | 2000-10-25 |
| TOTAL PSA MICROTITER ELISA (K002121) | Oncogene Science, Inc. | 2000-08-30 |
| COMPLEXED PSA MICROTITER ELISA (K002313) | Oncogene Science, Inc. | 2000-08-30 |
| FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM (K994419) | Qualisys Diagnostics, Inc. | 2000-06-28 |
| BAYER PSA ASSAY (K994221) | Bayer Corp. | 2000-04-13 |
| MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS (K000566) | Ortho-Clinical Diagnostics, Inc. | 2000-03-09 |
| QUALISYS PSA IMMUNOASSAY (K990234) | Qualisys Diagnostics, Inc. | 1999-07-08 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK (K984289) | Ortho-Clinical Diagnostics, Inc. | 1999-03-12 |
| ELECSYS PSA, MODEL 2010 (K982949) | Boehringer Mannheim Corp. | 1998-10-27 |
| ELECSYS PSA, MODEL # ELECSYS 1010 (K982948) | Boehringer Mannheim Corp. | 1998-10-27 |
| BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS (K981634) | Biocircuits Corp. | 1998-10-13 |
| ACS:CENTAUR PSA2 IMMUNOASSAY (K981839) | Chiron Diagnostics Corp. | 1998-08-12 |
| ACTIVE PSA ELISA (DSL-10-9700) (K973243) | Diagnostic Systems Laboratories, Inc. | 1998-08-03 |
| ACTIVE PSA IRMA (DSL-9700) (K973244) | Diagnostic Systems Laboratories, Inc. | 1998-08-03 |
| THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K980376) | Bayer Corp. | 1998-04-23 |
| IMMULITE 2000 3RD GENERATION PSA (K974842) | Diagnostic Products Corp. | 1998-04-21 |
| ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY (K980716) | Nichols Institute Diagnostics | 1998-04-03 |
| ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229 (K974816) | Beckman Instruments, Inc. | 1998-02-20 |
| ELECSYS PSA (ON ELECSYS 1010) (K974189) | Boehringer Mannheim Corp. | 1998-01-06 |
| IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5) (K972021) | Diagnostic Products Corp. | 1997-10-31 |
| PROSTATE SPECIFIC ANTIGEN METHOD (K973101) | Dade Chemistry Systems, Inc. | 1997-09-18 |
| IMMULITE 2000 PSA (K972095) | Diagnostic Products Corp. | 1997-08-22 |
| ELECSYS PSA ASSAY (K964351) | Boehringer Mannheim Corp. | 1997-07-25 |
| OPUS PSA TEST SYSTEM (K964595) | Behring Diagnostics, Inc. | 1997-06-24 |
| ENZYMUN-TEST PSA (K965085) | Boehringer Mannheim Corp. | 1997-03-19 |