| OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN (K081615) | Olympus America, Inc. | 2009-03-18 |
| OLYMPUS AFP - ALPHA-FETOPROTEIN (K081709) | Olympus Life Science Research Europa GmbH (Europa) | 2009-03-16 |
| EUROIMMUN ANTI BP 180-4X ELISA (IGG) (K083615) | Euroimmun Us, Inc. | 2009-03-16 |
| IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID READER CHECK DEVICE, AND IMMUNOCAP RAPID QC1 (K081830) | Phadia AB | 2009-03-16 |
| VARELISA RECOMBI ANA SCREEN, MODEL 12 596 (K083188) | Phadia US, Inc. | 2009-03-13 |
| DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M (K083463) | Siemens Healthcare Diagnostics | 2009-03-13 |
| IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT (K083314) | Siemens Healthcare Diagnostics | 2009-03-11 |
| PATHFAST HSCRP (K083412) | Mitsubishi Kagaku Iatron | 2009-03-09 |
| ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS (K080481) | Beckman Coulter, Inc. | 2009-02-20 |
| HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER (K082129) | The Binding Site, Ltd. | 2009-02-10 |
| MODIFICATION TO PAXGENE BLOOD RNA SYSTEM (K082150) | Preanalytix GmbH | 2009-02-04 |
| S-TEST C-REACTIVE PROTEIN (CRP) (K083040) | Alfa Wassermann Diagnostic Technologies, Inc. | 2009-01-30 |
| DIAZYME LP(A) ASSAY (K082488) | General Atomics | 2009-01-13 |
| HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS (K081827) | The Binding Site, Ltd. | 2008-12-19 |
| DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL (K082503) | Siemens Healthcare Diagnostics | 2008-12-19 |
| DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426 (K071474) | Siemens Healthcare Diagnostics | 2008-12-10 |
| QUANTA LITE OMP PLUS ELISA (K081248) | Inova Diagnostics, Inc. | 2008-10-27 |
| ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000 (K080909) | Ikonisys, Inc. | 2008-10-17 |
| BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG) (K081674) | The Binding Site, Ltd. | 2008-10-15 |
| VIDAS CEA (S) ASSAY (K080194) | bioMerieux, Inc. | 2008-10-09 |
| VIDAS AFP ASSAY (K080017) | bioMerieux, Inc. | 2008-09-26 |
| ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP (K081338) | Roche Diagnostics | 2008-09-11 |
| MESACUP MODELS BP180 AND BP230 ELISA KITS (K071961) | Mbl International Corporation | 2008-08-25 |
| ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495 (K080634) | Beckman Coulter, Inc. | 2008-08-11 |
| DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA (K081299) | Siemens Healthcare Diagnostics, Inc. | 2008-08-08 |
| ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS (K081294) | Siemens Healthcare Diagnostics, Inc. | 2008-07-29 |
| ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB (K080092) | Roche Diagnostics Corp. | 2008-07-28 |
| DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST (K081161) | Dade Behring, Inc. | 2008-07-28 |
| DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM (K081249) | Dade Behring, Inc. | 2008-07-21 |
| MODIFICATION TO MAMMAPRINT (K080252) | Agendia BV | 2008-07-21 |
| AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101 (K072901) | Amdl, Inc. | 2008-07-01 |
| CAPILLARYS URINE (K080916) | Sebia | 2008-07-01 |
| DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) (K071603) | Dade Behring, Inc. | 2008-06-25 |
| KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT (K080523) | Kronus Market Development Associates, Inc. | 2008-06-17 |
| HE4 EIA, MODEL: 404-10 US (K072939) | Fujirebio Diagnostics,Inc. | 2008-06-09 |
| DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600 (K071597) | Dade Behring, Inc. | 2008-06-04 |
| KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT (K080159) | Kronus Market Development Associates, Inc. | 2008-05-22 |
| HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM (K081217) | Hycor Biomedical, Inc. | 2008-05-22 |
| MODIFICATION TO AESKULISA DS DNA G (K081251) | Aesku Diagnostics | 2008-05-13 |
| AESKULISA ANA HEP-2, REF 30-7115US (K081104) | Aesku Diagnostics | 2008-05-02 |
| KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT (K073590) | Kronus Market Development Associates, Inc. | 2008-04-10 |
| IGG ANTI-ATHEROX TEST KIT (K072032) | Corgenix, Inc. | 2008-04-04 |
| ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS (K072658) | Siemens Medical Solutions Diagnostics | 2008-04-01 |
| INPLEX CF MOLECULAR TEST (K063787) | Third Wave Technologies, Inc. | 2008-03-13 |
| ROCHE-CREACTIVE PROTEIN (LATEX) (K073277) | Roche Diagnostics Corp. | 2008-03-06 |
| HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200 (K080322) | Hycor Biomedical, Inc. | 2008-03-05 |
| QUANTA LITE CCP3.1 IGG/IGA ELISA (K072944) | Inova Diagnostics, Inc. | 2008-03-05 |
| DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR (K073561) | Dade Behring, Inc. | 2008-02-26 |
| CELLSEARCH CIRCULATING TUMOR CELL KIT (K073338) | Veridex, LLC | 2008-02-26 |
| QUANTA LITE H-TTG SCREEN (K073145) | Inova Diagnostics, Inc. | 2008-02-12 |
| QUANTA PLEX CELIAC IGG PROFILE (K072632) | Inova Diagnostics, Inc. | 2008-02-11 |
| OLYMPUS IGA REAGENT (K073489) | Olympus America, Inc. | 2008-02-11 |
| OLYMPUS IGG REAGENT (K073490) | Olympus America, Inc. | 2008-02-11 |
| OLYMPUS IGM REAGENT (K073487) | Olympus America, Inc. | 2008-02-11 |
| HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER (K072889) | The Binding Site, Ltd. | 2008-02-01 |
| QUANTA LITE F-ACTIN IGA ELISA (K072967) | Inova Diagnostics, Inc. | 2008-01-28 |
| ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 (K072149) | Phadia US, Inc. | 2008-01-15 |
| EUROIMMUN ANTI-CCP ELISA (K070789) | Euroimmun Us, LLC | 2007-12-31 |
| DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON (K072965) | Dade Behring, Inc. | 2007-12-21 |
| MODIFICATION TO FIDIS VASCULITIS, MODEL MX007 (K070458) | Biomedical Diagnostics (Bmd) SA | 2007-12-21 |
| CAPILLARYS URINE (PN 2012) (K070486) | Sebia, Inc. | 2007-12-21 |
| PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109 (K072599) | Diadexus, Inc. | 2007-12-20 |
| MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006 (K071210) | Biomedical Diagnostics (Bmd) SA | 2007-12-19 |
| QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 (K072078) | Biokit, S.A. | 2007-12-19 |
| ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01 (K072393) | Phadia US, Inc. | 2007-12-07 |
| ATHENA MULTI-LYTE GBM TEST SYSTEM (K071219) | Zeus Scientific, Inc. | 2007-12-06 |
| LEUKO EZ VUE (K071712) | Techlab Inc., Corporate Research Center | 2007-12-04 |
| FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT (K070900) | The Binding Site, Ltd. | 2007-11-30 |
| IMMUNOCAP THYRLOBULIN IMMUNOCAP (K072661) | Phadia US, Inc. | 2007-11-20 |
| CELLSEARCH CIRCULATING TUMOR CELL KIT (K071729) | Veridex, LLC | 2007-11-20 |
| KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT (K072135) | Kronus Market Development Associates, Inc. | 2007-11-07 |
| ASCA-CHEK (K071711) | Techlab Inc., Corporate Research Center | 2007-11-07 |
| THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS (K071692) | Theratest Laboratories, Inc. | 2007-11-05 |
| IMMULITE 2500 OM-MA, MODEL L5KOP (K072794) | Siemens Medical Solutions Diagnostics | 2007-11-05 |
| BIOPLEX VASCULITIS KIT (K072358) | Bio-Rad Laboratories | 2007-10-31 |
| ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647 (K072612) | Beckman Coulter, Inc. | 2007-10-26 |
| LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH (K063838) | Thermo Electron OY | 2007-09-27 |
| CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01 (K062028) | Celera Diagnostics | 2007-09-07 |
| IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01 (K071913) | Phadia AB | 2007-08-24 |
| TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS (K063086) | Thermo Electron OY | 2007-08-08 |
| N LATEX RF KIT (K071247) | Dade Behring, Inc. | 2007-08-08 |
| I-CHROMA CRP TEST (K062981) | Boditech Diagnostics, Inc. | 2007-07-13 |
| KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT (K070183) | Kronus Market Development Associates, Inc. | 2007-07-13 |
| MAMMAPRINT (K070675) | Agendia BV | 2007-06-22 |
| IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT (K071002) | Beckman Coulter, Inc. | 2007-06-21 |
| FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER (K062372) | The Binding Site, Ltd. | 2007-06-21 |
| QUANTA PLEX CELIAC IGA PROFILE (K063818) | Inova Diagnostics, Inc. | 2007-06-20 |
| HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356) (K063498) | Sebia | 2007-06-11 |
| EUROIMMUN ANA IFA: HEP-20-10 (K070763) | Euroimmun Us, LLC | 2007-05-22 |
| SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT (K070626) | Beckman Coulter, Inc. | 2007-05-04 |
| IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS) (K071017) | Siemens Medical Solutions Diagnostics | 2007-05-02 |
| TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C (K063766) | Good Biotech Corp. | 2007-04-23 |
| QUANTA LITE RNA POL III ELISA (K070066) | Inova Diagnostics, Inc. | 2007-04-11 |
| QUANTA LITE SS-A 52 ELISA (K063565) | Inova Diagnostics, Inc. | 2007-04-04 |
| DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H (K063663) | Dade Behring, Inc. | 2007-03-21 |
| AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10 (K063347) | Axis-Shield Diagnostics, Ltd. | 2007-03-20 |
| COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL (K063150) | Thermo Electron OY | 2007-03-19 |
| ELIA GLIADIN IGA, IGG AND CELIAC CONTROL (K063775) | Phadia US, Inc. | 2007-03-14 |
| QUANTA LITE H-TTG/DGP SCREEN (K070083) | Inova Diagnostics, Inc. | 2007-03-12 |
| DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH (K063425) | Dade Behring, Inc. | 2007-02-15 |