| 134960 | 2057245374 | K993299 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 | GKP | 1999-12-07 |
| 134960 | 1310876078 | K992834 | GEM PREMIER 3000 | CHL | 1999-11-24 |
| 134960 | 1644711936 | K990346 | BAYER ADVIA 1650 CHEMISTRY SYSTEM | JGS | 1999-05-21 |
| 134960 | 1465689044 | K981761 | SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER | GKL | 1998-08-14 |
| 134960 | 1457280656 | K981743 | OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER | CKB | 1998-06-09 |
| 134960 | 1626410318 | K974784 | AVL OPTI CRITICAL CARE ANALYZER | CEM | 1998-02-24 |
| 134960 | 1086844896 | K974651 | ABBOTT AXSYM SYSTEM | JJE | 1998-02-12 |
| 134960 | 1709521672 | K971418 | CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER | MOI | 1997-07-17 |
| 134960 | 1941217386 | K971103 | AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM | KHO | 1997-06-27 |
| 134960 | 1241881229 | K970227 | IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER | JJE | 1997-04-08 |
| 134960 | 1707669940 | K962919 | VITROS IMMUNODIAGNOSTIC SYSTEM | KHO | 1996-10-18 |
| 134960 | 1483005222 | K962294 | IMMAGE IMMUNOCHEMISTRY SYSTEM | JQX | 1996-08-21 |
| 134960 | 1572302634 | K962021 | CIBA CORNING 348 SYSTEM | CHL | 1996-06-24 |
| 134960 | 1986676506 | K961991 | ACL 6000 SYSTEM (ACL 6000) | GKP | 1996-09-04 |
| 134960 | 1338815728 | K961481 | ELECSYS 2010 ANALYZER | JJE | 1996-06-14 |
| 134960 | 1643184804 | K961458 | AVL 9180 ELECTROLYTE ANALYZER | JFP | 1996-06-12 |
| 134960 | 1797058430 | K961274 | OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER | JJE | 1996-07-05 |
| 134960 | 1765292973 | K953239 | BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER | JJE | 1995-09-25 |
| 134960 | 1374856796 | K951595 | ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES | CGX | 1995-09-08 |
| 134960 | 1096896721 | K946206 | CIBA CORNING 8-- SERIES CO-OXIMETER | CHL | 1995-01-30 |
| 134960 | 2059434171 | K946183 | CLINITEK ATLAS AUTOMATED URINE CHEMISTRY ANALYZER | KQO | 1995-02-22 |
| 134960 | 1775766035 | K946090 | KODAK EKTACCHEM 950IRC ANALYZER | JJE | 1995-01-17 |
| 134960 | 1658984970 | K945271 | ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM | JJE | 1995-04-20 |
| 134960 | 1632392562 | K944093 | DIMENSION(R) XL CLINICAL CHEMISTRY SYSTEM | JJE | 1994-11-10 |
| 134960 | 2069115071 | K935830 | CIBA CORNING 248 PH/BLOOD GAS ANALYZER | CHL | 1994-02-03 |
| 134960 | 1938548931 | K934592 | EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR | JJG | 1994-04-06 |
| 134960 | 1410164388 | K932674 | CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM | KQO | 1993-08-19 |
| 134960 | 1134865326 | K931786 | ACE CLINICAL CHEMISTRY SYSTEM | JJE | 1993-09-21 |
| 134960 | 1042272048 | K923021 | AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM | KHO | 1992-07-21 |
| 134960 | 1772560612 | K922072 | KODAK EKTACHEM 250 ANALYER | JJE | 1992-07-10 |
| 134960 | 1908233299 | K921661 | BOEHRINGER MANNHEIM/ HITACHI 911 ANALYZER | JJE | 1992-06-30 |
| 134960 | 1417630021 | K920402 | ROCHE COBAS MIRA PLUS | JJE | 1992-04-29 |
| 134960 | 1339492450 | K905215 | IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER | JJQ | 1991-01-11 |
| 134960 | 1236096600 | K901674 | AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM | KHO | 1990-05-02 |
| 134960 | 1414283651 | K881495 | SYNCHRON CX(TM)5 CLINICAL ANALYZER | JJE | 1988-06-01 |
| 134960 | 1323660355 | K872494 | HITACHI 717 CHEMISTRY ANALYZER | JJE | 1987-07-09 |
| 134960 | 1579120608 | K851172 | COBAS MIRA | JJF | 1985-05-02 |
| 134960 | 1450276803 | K823480 | IL 943 FLAME PHOTOMETER | JJO | 1983-01-09 |
| 134960 | 1780174104 | K230790 | Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series | DHA | 2023-05-19 |
| 134960 | 1045229343 | K222116 | Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP) | JLW | 2023-07-13 |
| 134960 | 1631082379 | K221225 | Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer | JLW | 2022-11-10 |
| 134960 | 1708731861 | K220134 | cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH | CFR | 2022-09-16 |
| 134960 | 1669290314 | K220031 | Alinity h-series System | GKZ | 2023-08-04 |
| 134960 | 1586859352 | K212183 | STA R Max 3, STA Compact Max 3 | JPA | 2023-06-07 |
| 134960 | 1249862048 | K203790 | GEM Premier 5000 | CHL | 2021-08-20 |
| 134960 | 1321667132 | K193124 | Unicel DxH 800 Coulter Cellular Analysis System | GKZ | 2020-04-16 |
| 134960 | 1701176311 | K190294 | CELL-DYN Emerald 22 AL System | GKZ | 2019-03-15 |
| 134960 | 1014970786 | K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System | JFY | 2018-10-30 |
| 134960 | 1970984317 | K181289 | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System | OCC | 2018-08-15 |
| 134960 | 1518373726 | K171883 | Sysmex UF-5000 Fully Automated Urine Particle Analyzer | LKM | 2018-04-23 |
| 134960 | 1535510020 | K170317 | Alinity i Total ß-hCG Reagent Kit, Alinity i System | DHA | 2017-10-23 |
| 134960 | 2043655762 | K163342 | i-STAT Hematocrit test with i-STAT Alinity System | JPI | 2017-08-22 |
| 134960 | 1178542029 | K161837 | ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer | JGS | 2016-12-16 |
| 134960 | 1195162856 | K160276 | ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) | GKP | 2016-03-03 |
| 134960 | 1956991793 | K151792 | Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System | JLW | 2015-11-20 |
| 134960 | 1729828082 | K151565 | Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit | OUY | 2015-10-16 |
| 134960 | 1944988725 | K151259 | Sysmex Automated Blood Coagulation Analyzer CS-2100i | JPA | 2016-01-26 |
| 134960 | 1869372924 | K150877 | ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS | GKP | 2015-12-13 |
| 134960 | 1587847309 | K150678 | Sysmex Automated Blood Coagulation Analyzer CS-5100 | JPA | 2016-01-11 |
| 134960 | 1731088855 | K143720 | Dimension Vista MMB Assay | JHY | 2015-09-18 |
| 134960 | 1370752861 | K141681 | SYSMEX XN SERIES | GKZ | 2014-12-05 |
| 134960 | 1597731572 | K140887 | COBAS CT/NG V2.0 TEST | LSL | 2014-05-05 |
| 134960 | 1153896657 | K131126 | OPTI CCA-TS2 | CHL | 2013-08-22 |
| 134960 | 1086868202 | K130276 | DIMENSION EXL WITH LM SYSTEM | JJE | 2013-03-22 |
| 134960 | 1275090412 | K130090 | STA COMPACT MAX | JPA | 2013-02-12 |
| 134960 | 1524428047 | K123955 | QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT | OOI | 2013-03-08 |
| 134960 | 1539538257 | K123018 | ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE | CFR | 2013-04-23 |
| 134960 | 1380918465 | K112755 | ABACUS 5 | GKZ | 2012-03-27 |
| 134960 | 1808386555 | K112605 | SYSMEX XN-SERIES | GKZ | 2012-10-19 |
| 134960 | 1847994800 | K112412 | AU5800(R) CHEMISTRY ANALYZER | CEM | 2011-12-23 |
| 134960 | 1658784561 | K111534 | ABACUS 3CP | GKZ | 2012-08-02 |
| 134960 | 1287141143 | K110520 | BIOLIS 12I | CEM | 2012-03-23 |
| 134960 | 1949206746 | K110381 | CELL-DYN EMERALD 22 SYSTEM | GKZ | 2011-12-22 |
| 134960 | 1328323405 | K110035 | INDIKO | JJE | 2011-06-28 |
| 134960 | 1676119152 | K103531 | PRESTIGE 24I; BIOLIS 24I; MGC 240 | CFR | 2011-12-01 |
| 134960 | 1628178340 | K103529 | LIAISON XL ANALYZER MODEL 10050 | LOL | 2011-01-21 |
| 134960 | 1889087887 | K103195 | I-STAT 1 WIRELESS ANALYZER | CGA | 2011-02-08 |
| 134960 | 1198017811 | K102647 | ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE... | JGS | 2011-03-24 |
| 134960 | 1560148320 | K101852 | CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT | KQO | 2011-03-23 |
| 134960 | 1772125830 | K101741 | DIATRON PICTUS 400 | CGA | 2011-01-25 |
| 134960 | 1061158106 | K100853 | COBAS 8000 MODULAR SERIES ANALYZER | DCF | 2010-09-09 |
| 134960 | 1091257742 | K093861 | IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE | LKM | 2010-02-05 |
| 134960 | 1977615386 | K093555 | COBAS U411 TEST SYSTEM | KQO | 2010-04-02 |
| 134960 | 1352732936 | K093383 | NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG | OOI | 2010-07-06 |
| 134960 | 1491909372 | K093167 | STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER | JPA | 2009-12-22 |
| 134960 | 1612814408 | K092705 | ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501 | OOI | 2010-05-28 |
| 134960 | 1128399869 | K092686 | ABL90 FLEX SERIES | CEM | 2010-08-06 |
| 134960 | 1757963186 | K091313 | SYSMEX MODEL XT-4000I | GKZ | 2010-03-30 |
| 134960 | 1175214874 | K090703 | POLY-CHEM 90 GLUCOSE | CFR | 2009-10-20 |
| 134960 | 1759578440 | K090332 | ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001 | NBW | 2009-08-14 |
| 134960 | 1179077740 | K083339 | DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) | CIC | 2009-03-09 |
| 134960 | 1899350005 | K083173 | VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM | JLW | 2008-12-22 |
| 134960 | 1823148458 | K082675 | STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER | JPA | 2008-10-10 |
| 134960 | 1907416551 | K082562 | APPLIED BIOSYSTEMS 7500 FAST DX | NSU | 2008-09-30 |
| 134960 | 1474026266 | K082248 | STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER | JPA | 2008-12-12 |
| 134960 | 1489501890 | K081495 | CELL-DYN EMERALD SYSTEM | GKZ | 2009-02-04 |
| 134960 | 1586164006 | K080370 | ABL 80 CO-OX SYSTEM | CHL | 2008-07-31 |
| 134960 | 1598710507 | K072018 | BS-200 CHEMISTRY ANALYZER, MODE BS-200 | CFR | 2008-02-01 |
| 134960 | 1981491598 | K071211 | COBAS C 111 ANALYZER | CIT | 2007-07-30 |
| 134960 | 2073030054 | K071132 | G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8 | LCP | 2008-09-16 |
| 134960 | 1696941728 | K070910 | SYSMEX MODEL UF1000I | LKM | 2007-05-25 |
| 134960 | 1129730480 | K063434 | TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM | DQA | 2007-01-22 |
| 134960 | 1271036977 | K061974 | GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT | CHL | 2006-09-15 |
| 134960 | 1729666937 | K061667 | CELL-DYN RUBY SYSTEM | GKZ | 2006-07-10 |
| 134960 | 1211283934 | K061138 | ABX PENTRA 400 : CRP | DCK | 2006-09-29 |
| 134960 | 1001909066 | K060656 | SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES | GKZ | 2006-05-10 |
| 134960 | 1453527444 | K060540 | XPERT, GENEXPERT DX SYSTEM | NJR | 2006-07-25 |
| 134960 | 1255485642 | K060373 | COBAS 6000 SERIES SYSTEM | CEM | 2006-03-13 |
| 134960 | 1265968106 | K060162 | ACL ELITE; ACL ELITE PRO | JPA | 2006-02-21 |
| 134960 | 1347441465 | K052914 | RX IMOLA | CEM | 2006-03-31 |
| 134960 | 1213288349 | K052007 | ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE) | CFR | 2005-12-16 |
| 134960 | 1097033508 | K051693 | MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM | GKL | 2005-12-07 |
| 134960 | 1542269636 | K051215 | CELL-DYN SAPPHIRE SYSTEM | GKZ | 2005-07-21 |
| 134960 | 1215017849 | K042169 | STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER | JJE | 2005-03-14 |
| 134960 | 1477132802 | K041874 | ABL800 FLEX | CHL | 2004-10-08 |
| 134960 | 1690920921 | K041133 | MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER | CDD | 2004-07-02 |
| 134960 | 1832540445 | K040958 | PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240 | JJE | 2005-02-15 |
| 134960 | 1596868812 | K033734 | LIGHTCYCLER INSTRUMENT VERSION 1.2 | JJF | 2003-12-17 |
| 134960 | 2064463610 | K033234 | IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER | DHA | 2003-12-12 |
| 134960 | 1657709346 | K032677 | SYSMEX POCH-100I | GKL | 2004-02-11 |