| VIDAS FREE PSA RT ASSAY (P080008) | bioMerieux, Inc. | 2009-10-08 |
| ADVIA CENTAUR XP PSA ASSAY ON THE ADVIA CENTAUR XP (WITH VERSION 5.0 SOFTWARE) (P950021/S011) | Siemens Healthcare Diagnostics | 2009-06-10 |
| ADVIA CENTAUR XP CPSA ASSAY ON THE ADVIA CENTAUR XP (WITH VERSION 5.0 SOFTWARE) (P990055/S012) | Siemens Healthcare Diagnostics | 2009-06-10 |
| DIMENSION RXL MAX TPSA FLEX REAGENT CARTRIDGE (P000021/S014) | Siemens Healthcare Diagnostics | 2009-06-04 |
| ARCHITECT TOTAL PSA ASSAY (P910007/S017) | Abbott Laboratories | 2009-05-29 |
| MIGRATION OF THE ABBOTT ARCHITECT FREE PSA ASSAY TO THE NEW ARCHITECT I1000 SYSTEM (P980007/S009) | Abbott Laboratories | 2009-05-28 |
| AUTODELFIA HAFP KIT (P970037/S002) | Revvity, Inc. | 2009-04-08 |
| ADVIA CENTAUR PSA ASSAY (P950021/S010) | Siemens Healthcare Diagnostics | 2009-03-06 |
| ADVIA CENTAUR PSA & CPSA ASSAYS (P990055/S011) | Siemens Healthcare Diagnostics | 2009-03-06 |
| ELECSYS FREE PSA IMMUNOASSAY, PSA CALSET & PSA CALCHECK (P000027/S005) | Roche Diagnostics Corp. | 2009-03-03 |
| IMMULITE/IMMULITE 1000 & IMMULITE 2000 FREE PSA (P060005/S001) | Siemens Medical Solutions Diagnostics Limited | 2008-12-30 |
| IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2500 PSA & 3RD GENERATIONPSA (P930027/S007) | Siemens Healthcare Diagnostics, Inc. | 2008-12-30 |
| ELECSYS TOTAL PSA IMMUNOASSAY AND ELECYS TOTAL PSA CALSET (P990056/S007) | Roche Diagnostics Corp. | 2008-11-18 |
| ELECSYS TOTAL PSA TEST SYSTEM ON COBAS E 601 IMMUNOASSAY ANALYZER (P990056/S008) | Roche Diagnostics Corp. | 2008-10-17 |
| ELECSYS FREE PSA TEST SYSTEM ON COBAS E 601 IMMUNOASSAY ANALYZER (P000027/S006) | Roche Diagnostics Corp. | 2008-10-17 |
| VIDAS TOTAL PSA (TPSA) ASSAY (P040008/S001) | bioMerieux, Inc. | 2008-09-25 |
| ELECSYS TOTAL PSA (P990056/S009) | Roche Diagnostics Corp. | 2008-09-17 |
| ELECSYS FREE PSA (P000027/S007) | Roche Diagnostics Corp. | 2008-09-17 |
| ACCESS HYBRITECH FREE PSA ASSAY (P970038/S012) | Beckman Coulter, Inc. | 2008-08-13 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (P980041/S012) | Beckman Coulter, Inc. | 2008-07-28 |
| NMP22 ELISA TEST KIT (P940035/S005) | Abbott Diagnostics Scarborough, Inc. | 2008-06-03 |
| ABBOTT ARCHITECT AFP (P820060/S023) | Abbott Laboratories | 2008-05-21 |
| NMP22 BLADDERCHEK TEST KIT (P940035/S004) | Abbott Diagnostics Scarborough, Inc. | 2008-05-20 |
| ACCESS HYBRITECH PSA WHO STANDARDIZATION (P850048/S021) | Beckman Coulter, Inc. | 2008-05-09 |
| ABBOTT AXSYM AFP (P820060/S022) | Abbott Laboratories | 2008-03-26 |
| ACCESS AFP ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S011) | Beckman Coulter, Inc. | 2008-03-26 |
| DIMENSION FPSA FLEX REAGENT (P020027/S008) | Siemens Healthcare Diagnostics | 2008-03-14 |
| TPSA FLEX REAGENT (P000021/S012) | Siemens Healthcare Diagnostics | 2008-03-14 |
| DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S011) | Siemens Healthcare Diagnostics | 2008-03-13 |
| DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S007) | Siemens Healthcare Diagnostics | 2008-03-13 |
| ACCESS HYBRITECT FREE PSA (P970038/S011) | Beckman Coulter, Inc. | 2008-03-06 |
| ACCESS HYBRITECH PSA IMMUNOASSAY (P850048/S023) | Beckman Coulter, Inc. | 2008-02-26 |
| IN VITRO DIAGNOSTIC PRODUCT ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S010) | Beckman Coulter, Inc. | 2007-11-27 |
| ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S009) | Beckman Coulter, Inc. | 2007-09-19 |
| ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P850048/S022) | Beckman Coulter, Inc. | 2007-09-18 |
| DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S006) | Siemens Healthcare Diagnostics | 2007-09-14 |
| DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S010) | Siemens Healthcare Diagnostics | 2007-09-14 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S009) | Beckman Coulter, Inc. | 2007-09-12 |
| ACCESS HYBRITECH FREE PSA (P970038/S010) | Beckman Coulter, Inc. | 2007-06-13 |
| IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYS (P060005) | Siemens Medical Solutions Diagnostics Limited | 2007-05-11 |
| IMX PSAS (P910007/S016) | Abbott Laboratories | 2007-02-01 |
| ABBOTT IMX FREE PSA (P980007/S008) | Abbott Laboratories | 2007-02-01 |
| ABBOTT AFP-EIA DIAGNOSTIC KIT (P820060/S021) | Abbott Laboratories | 2007-02-01 |
| ELECSYS TOTAL PSA CALSET (P990056/S006) | Roche Diagnostics Corp. | 2007-01-19 |
| ELECSYS FREE PSA CALSET AND (P000027/S004) | Roche Diagnostics Corp. | 2007-01-19 |
| DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S009) | Siemens Healthcare Diagnostics | 2007-01-04 |
| DIMENSION FPSA FLEX REAGENT CATRIDGE (P020027/S005) | Siemens Healthcare Diagnostics | 2007-01-04 |
| ADVIA IMS PROSTATE SPECIFIC ANTIGEN ASSAY (PSA) (P990055/S009) | Siemens Healthcare Diagnostics | 2006-11-06 |
| ADVIA IMS COMPLEXED PROSTATE SPECIFIC ANTIGEN ASSAY (CPSA) (P950021/S008) | Siemens Healthcare Diagnostics | 2006-11-06 |
| ELECSYS TOTAL PSA IMMUNOASSAY (P990056/S004) | Roche Diagnostics Corp. | 2006-10-13 |
| ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET (P990056/S003) | Roche Diagnostics Corp. | 2006-08-10 |
| ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P850048/S020) | Beckman Coulter, Inc. | 2006-05-18 |
| ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMUNOASSAY SYSTEMS (P970038/S008) | Beckman Coulter, Inc. | 2006-05-18 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S008) | Beckman Coulter, Inc. | 2006-05-16 |
| ELECSYS TOTAL PSA IMMUNOASSAY (P990056/S002) | Roche Diagnostics Corp. | 2006-04-12 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S007) | Beckman Coulter, Inc. | 2006-01-30 |
| AIA-PACK PA PSA, ST AIA-PACK PA PSA (P910065/S006) | Tosoh Bioscience, Inc. | 2005-11-30 |
| BAYER ADVIA IMS COMPLEXED PSA ASSAY (P990055/S008) | Siemens Healthcare Diagnostics | 2005-10-07 |
| ADVIA CENTAUR CP PSA ASSAY (P950021/S007) | Siemens Healthcare Diagnostics | 2005-10-07 |
| ACS 180/ADVIA CENTAUR AFP IMMUNOASSAY (P930036/S003) | Siemens Healthcare Diagnostics, Inc. | 2005-10-07 |
| ABBOTT IMX TOTAL PSA, ABBOTT AXSYM TOTAL PSA AND ABBOTT ARCHITECT TOTAL PSA (P910007/S015) | Abbott Laboratories | 2005-09-13 |
| DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S004) | Siemens Healthcare Diagnostics | 2005-07-13 |
| DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S008) | Siemens Healthcare Diagnostics | 2005-07-11 |
| ABBOTT IMX TOTAL PSA (P910007/S013) | Abbott Laboratories | 2005-06-13 |
| DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S006) | Siemens Healthcare Diagnostics | 2005-06-02 |
| DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S003) | Siemens Healthcare Diagnostics | 2005-06-02 |
| DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S002) | Siemens Healthcare Diagnostics | 2005-02-11 |
| DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S005) | Siemens Healthcare Diagnostics | 2005-02-11 |
| DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S004) | Siemens Healthcare Diagnostics | 2004-12-02 |
| ABBOTT AXSYM TOTAL PSA ASSAY (P910007/S011) | Abbott Laboratories | 2004-09-27 |
| ABBOTT ARCHITECT FREE PSA (P980007/S006) | Abbott Laboratories | 2004-09-10 |
| ABBOTT AXSYM FREE PSA ASSAY (P980007/S005) | Abbott Laboratories | 2004-09-10 |
| ABBOTT ARCHITECT TOTAL PSA (P910007/S012) | Abbott Laboratories | 2004-09-10 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (P980041/S006) | Beckman Coulter, Inc. | 2004-08-04 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (P980041/S005) | Beckman Coulter, Inc. | 2004-07-15 |
| VIDAS TPSA ASSAY (P040008) | bioMerieux, Inc. | 2004-07-08 |
| ST AIA-PACK PA (P910065/S005) | Tosoh Bioscience, Inc. | 2004-05-25 |
| ABBOTT ARCHITECT FREE PSA (P980007/S004) | Abbott Laboratories | 2004-05-07 |
| ABBOTT ARCHITECT TOTAL PSA ASSAY (P910007/S010) | Abbott Laboratories | 2004-04-28 |
| ABBOTT AXSYM FREE PSA (P980007/S001) | Abbott Laboratories | 2004-04-15 |
| ABBOTT AXSYM/TOTAL PSA (P910007/S006) | Abbott Laboratories | 2004-03-03 |
| ABBOTT IMX FREE PSA (P980007/S003) | Abbott Laboratories | 2004-02-05 |
| AXSYM FREE PSA (P980007) | Abbott Laboratories | 2004-02-05 |
| ABBOTT ARCHITECT FREE PSA (P980007/S002) | Abbott Laboratories | 2004-02-05 |
| ABBOTT ARCHITECT TOTAL PSA (P910007/S007) | Abbott Laboratories | 2004-02-02 |
| ABBOTT ARCHITECHT AFP (P820060/S013) | Abbott Laboratories | 2004-02-02 |
| ABBOTT AXSYM AFP (P820060/S019) | Abbott Laboratories | 2004-02-02 |
| ABBOTT ARCHITECT AFP FOR THE ARCHITECT I2000SR ANALYZER (P820060/S016) | Abbott Laboratories | 2004-02-02 |
| ABBOTT IMX TOTAL PSA (P910007/S009) | Abbott Laboratories | 2004-02-02 |
| ABBOTT AXSYM TOTAL PSA (P910007/S005) | Abbott Laboratories | 2004-02-02 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (P980041/S004) | Beckman Coulter, Inc. | 2004-01-20 |
| IMMULITE 2500 PSA, IMMULITE 2500 THIRD GENERATION PSA (P930027/S006) | Siemens Healthcare Diagnostics, Inc. | 2003-12-31 |
| IMMULITE 2500 AFP, MODEL L5KAP (P010007/S002) | Siemens Healthcare Diagnostics, Inc. | 2003-12-31 |
| DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S003) | Siemens Healthcare Diagnostics | 2003-12-30 |
| DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S001) | Siemens Healthcare Diagnostics | 2003-10-10 |
| BAYER ADVIA IMS PSA ASSAY (P950021/S006) | Siemens Healthcare Diagnostics | 2003-09-02 |
| BAYER ADVIA IMS CPSA ASSAY (P990055/S007) | Siemens Healthcare Diagnostics | 2003-09-02 |
| ST AIA-PACK PA (P910065/S004) | Tosoh Bioscience, Inc. | 2003-08-12 |
| ACS: 180 AND ADVIA CENTAUR COMPLEXED PSA (CPSA) IMMUNOASSAYS (P990055/S006) | Siemens Healthcare Diagnostics | 2003-05-09 |
| NMP22 BLADDERCHEK TEST KIT (P940035/S003) | Abbott Diagnostics Scarborough, Inc. | 2003-04-25 |