meddevicedb.com FDA Device Reference

Review Panel

Immunology FDA 510(k) Clearances & Devices

Cleared Devices
3,548
Product Codes (page)
48
Latest Decision
2007-05-04

Clearances · page 7 of 36

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K070626 SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT Beckman Coulter, Inc. NQD Class II 2007-05-04
K071017 IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS) Siemens Medical Solutions Diagnostics NQD Class II 2007-05-02
K063766 TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C Good Biotech Corp. DDG Class II 2007-04-23
K070066 QUANTA LITE RNA POL III ELISA Inova Diagnostics, Inc. NYO Class II 2007-04-11
K063565 QUANTA LITE SS-A 52 ELISA Inova Diagnostics, Inc. OBE Class II 2007-04-04
K063663 DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H Dade Behring, Inc. DDG Class II 2007-03-21
K063347 AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10 Axis-Shield Diagnostics, Ltd. NHX Class II 2007-03-20
K063150 COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL Thermo Electron OY CZW Class II 2007-03-19
K063775 ELIA GLIADIN IGA, IGG AND CELIAC CONTROL Phadia US, Inc. MST Class II 2007-03-14
K070083 QUANTA LITE H-TTG/DGP SCREEN Inova Diagnostics, Inc. MST Class II 2007-03-12
K063655 DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH Dade Behring, Inc. CHN Class II 2007-02-15
K063425 DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH Dade Behring, Inc. DGC Class II 2007-02-15
DEN070009 MAMMAPRINT Agendia BV NYI Class II 2007-02-06
K062114 CERULOPLASMIN, MODEL 2055953 Roche Diagnostics Corp. CHN Class II 2007-01-31
K062368 WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401 Wako Chemicals USA, Inc. OAU Class II 2007-01-31
K063272 DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH Dade Behring, Inc. JZG Class II 2007-01-26
K063322 DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H Dade Behring, Inc. DDG Class II 2007-01-24
K063610 DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH Dade Behring, Inc. DEM Class II 2007-01-11
K062787 ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01 Phadia US, Inc. MVM Class II 2006-12-29
K062924 STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK Dade Behring, Inc. NQD Class II 2006-12-26
K062583 ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01 Phadia US, Inc. MVM Class II 2006-12-26
K063057 IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP Diagnostic Products Corporation NQD Class II 2006-12-22
K062013 CELLSEARCH CIRCULATING TUMOR CELL KIT Veridex, LLC NQI Class II 2006-12-14
K062708 QUANTA LITE CELIAC DGP SCREEN Inova Diagnostics, Inc. MST Class II 2006-12-13
K062217 AESKULSKA BETA2-GLYCO-A Aesku, Inc. MSV Class II 2006-12-13
K062045 EDIA ANTI-CCP Euro-Diagnostica AB NHX Class II 2006-12-04
K062183 FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT The Binding Site, Ltd. LRM Class II 2006-11-21
K061794 FIDIS TM THYRO, MODEL MX002 Biomedical Diagnostics (Bmd) SA JZO Class II 2006-11-21
K062746 FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 Medicon Hellas S.A DBF Class II 2006-11-20
K061842 QUANTA LITE PBC SCREEN IGG/IGA ELISA Inova Diagnostics, Inc. NRI Class II 2006-10-18
K062516 ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS) Beckman Coulter, Inc. JNL Class II 2006-10-05
K061408 EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT Euroimmun Us, LLC MVM Class II 2006-10-05
K061138 ABX PENTRA 400 : CRP Horiba Abx DCK Class II 2006-09-29
K061852 DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH Dade Behring, Inc. CZW Class II 2006-09-22
K061990 DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL Dade Behring, Inc. DCF Class II 2006-09-19
K062234 MODIFICATION TO DIADEXUS PLAC TEST Diadexus, Inc. NOE Class II 2006-09-11
K061802 DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH Dade Behring, Inc. NQD Class II 2006-09-11
K060700 EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT. Euroimmun Us, LLC MOB Class II 2006-09-08
K061825 DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH Dade Behring, Inc. DCN Class II 2006-09-06
K061970 ELECSYS IGE II IMMUNOASSAY Roche Diagnostics JHR Class II 2006-08-31
K061845 DIMENSION VISTA IGM FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H Dade Behring, Inc. CFN Class II 2006-08-24
K061165 ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01 Sweden Diagnostics (Us), Inc. NHX Class II 2006-08-03
K061683 TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM Roche Diagnostics Corp. DDR Class II 2006-07-21
K061376 EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3 Theratest Laboratories, Inc. MOB Class II 2006-07-20
K052407 ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS Fisher Diagnostics JZO Class II 2006-07-18
K061069 SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458 Helena Laboratories CFF Class II 2006-07-06
K061382 ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227 Beckman Coulter, Inc. JZO Class II 2006-07-06
K061338 DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY Dade Behring, Inc. CFN Class II 2006-07-06
K060431 ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805 Mbl International Corporation NYO Class II 2006-06-19
K060627 TAG-IT CYSTIC FIBROSIS KIT Tm Bioscience Corporation NUA Class II 2006-06-07
K060201 OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105. Olympus America, Inc. DHR Class II 2006-06-06
K060157 IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA Immco Diagnostics, Inc. MVM Class II 2006-05-25
K052308 ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM Fisher Diagnostics JZO Class II 2006-05-10
K060369 STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK Dade Behring, Inc. NQD Class II 2006-05-04
K060380 FIDIS DSDNA Biomedical Diagnostics (Bmd) SA LSW Class II 2006-05-02
K060139 CRP-ADVANCE ASSAY, MODELS 250-20, 250-25 Diagnostic Chemicals , Ltd. DCK Class II 2006-04-28
DEN060001 PHICAL TEST Genova Diagnostics NXO Class II 2006-04-26
K051927 TECHLAB ASCA-CHEK Techlab, Inc. NBT Class II 2006-04-06
K053383 FIDIS CELIAC Biomedical Diagnostics (Bmd) SA MST Class II 2006-03-29
K053072 N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN Dade Behring, Inc. DEM Class II 2006-03-28
K060543 ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800 Clinical Micro Sensors, Inc. NUA Class II 2006-03-28
K053073 N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN Dade Behring, Inc. DEB Class II 2006-03-28
K053074 N ANTISERA TO HUMAN CERULOPLASMIN Dade Behring, Inc. DDB Class II 2006-03-16
K060110 CELLTRACKS ANALYZER II Immunicon Corp. NQI Class II 2006-03-16
K053075 N ANTISERA TO HUMAN TRANSFERRIN Dade Behring, Inc. DDG Class II 2006-03-16
K053211 RDI HSFERRITIN KIT Reference Diagnostics, Inc. DBF Class II 2006-03-13
K053653 FIDIS CONNECTIVE 10, MODEL MX006 Biomedical Diagnostics (Bmd) SA LLL Class II 2006-03-13
K053553 NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL Polymedco, Inc. DCF Class II 2006-03-09
K053012 FIDIS VASCULITIS, MODEL MX007 Biomedical Diagnostics (Bmd) SA MOB Class II 2006-03-02
K052617 FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H, Good Biotech Corp. DBF Class II 2006-02-23
K051489 EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM Euroimmun Us, LLC MOB Class II 2006-02-16
K060130 IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT Beckman Coulter, Inc. CZP Class II 2006-02-13
K053603 C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS Roche Diagnostics Corp. NQD Class II 2006-02-09
K052591 NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT Clinical Data, Inc. DCK Class II 2006-02-09
K052439 AESKULISA GLIA A AND AESKULISA GLIA G Aesku Diagnostics MST Class II 2006-02-07
K060176 EL-ACL SCREEN; EL-ACL IGM, IGG, IGA Theratest Laboratories, Inc. MID Class II 2006-02-07
K052793 IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02 Pharmacia Diagnostics AB MST Class II 2006-02-07
K053426 ROCHE ELECSYS ANTI-TG Roche Diagnostics Corp. JZO Class II 2006-02-07
K051677 OPTIGEN ALLERGEN SPECIFIC IGE ASSAY Hitachi Chemical Diagnostics, Inc. DHB Class II 2006-01-23
K051435 ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800 Clinical Micro Sensors NUA Class II 2006-01-19
K050944 K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET Kamiya Biomedical Co. DBF Class II 2005-12-23
K053109 DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE Dade Behring, Inc. NQD Class II 2005-12-23
K052819 VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III Ortho-Clinical Diagnostics, Inc. DEM Class II 2005-12-23
K052889 VITROS CA 19-9 Fujirebio Diagnostics,Inc. NIG Class II 2005-12-20
K052133 IMMUNOSCAN RA ANTI-CCP TEST SYSTEM Eurodiagnostica NHX Class II 2005-12-12
K051299 IGD DIAGNOSTIC TEST KITS The Binding Site, Ltd. CZJ Class II 2005-11-23
K052264 QUANTA LITE CCP3 IGG ELISA Inova Diagnostics, Inc. NHX Class II 2005-11-23
K051455 WIESLAB CAP MPO-ANCA Eurodiagnostica MOB Class II 2005-11-23
K051458 WIESLAB CAP PR-3 ANCA Eurodiagnostica MOB Class II 2005-11-22
K051144 ACETYLCHOLINE RECEPTOR AB (ARAB)RRA Ibl-Hamburg GmbH NST Class II 2005-11-18
K051492 AESKULISA ASCA A Aesku, Inc. NBT Class II 2005-11-14
K051061 KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT Kronus Market Development Associates, Inc. NWG Class II 2005-11-04
K052262 QUANTA LITE M2 EP (MIT3) ELISA Inova Diagnostics, Inc. DBM Class II 2005-10-27
K052191 MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT Veridex, LLC NQI Class II 2005-10-27
K052000 ARCHITECT CA 19-9XR ASSAY Fujirebio Diagnostics,Inc. NIG Class II 2005-10-25
K051456 SENTINEL CERULOPLASMIN Sentinel Ch. Srl JFR Class II 2005-10-21
K051066 THERATEST EL-ANA PROFILES Theratest Laboratories, Inc. LKP Class II 2005-10-07
K052143 QUANTA LITE GLIADIN IGA II Inova Diagnostics, Inc. MST Class II 2005-10-04
K052142 QUANTA LITE GLIADIN IGG II Inova Diagnostics, Inc. MST Class II 2005-10-04
K050286 FIDIS CONNECTIVE 8 Biomedical Diagnostics (Bmd) SA LLL Class II 2005-10-03

3,548 clearances in the Immunology panel. Data: openFDA.