meddevicedb.com FDA Device Reference

Review Panel

Immunology FDA 510(k) Clearances & Devices

Cleared Devices
3,548
Product Codes (page)
54
Latest Decision
2014-12-15

Clearances · page 4 of 36

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K141575 PLAC TEST FOR LP-PLA2 ACTIVITY Diadexus, Inc. NOE Class II 2014-12-15
K140224 EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG) Euroimmun US LKO Class II 2014-12-09
K141771 PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY Nanostring Technologies, Inc. NYI Class II 2014-11-07
K140691 IG_PLEX CELIAC DGP PANEL Sqi Diagnostics Systems, Inc. MVM Class II 2014-11-06
K140493 ELIA SCL-70S IMMUNOASSAY Phadia GmbH LJM Class II 2014-10-30
K140225 ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO Phadia US, Inc. MOB Class II 2014-10-27
K142346 Urine/CSF Albumin, Urine/CSF Albumin Calibrator Beckman Coulter Ireland, Inc. DCF Class II 2014-10-15
K132631 EIA SMDP IMMUNOASSAY Phadia US, Inc. LKP Class II 2014-08-29
DEN140001 ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT Kronus Market Development Associates, Inc. PHF Class II 2014-08-20
K140686 HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS The Binding Site Group , Ltd. PDE Class II 2014-08-06
K141100 OPTILITE C1 INACTIVATOR KIT The Binding Site Group , Ltd. DBA Class II 2014-07-18
K133083 DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET Diazyme Laboratories DBF Class II 2014-06-24
K132801 IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY Siemens Healthcare Diagnostics, Inc. DHB Class II 2014-05-28
K130775 DUET SYSTEM Bioview , Ltd. NTH Class II 2014-05-09
K140396 FREELITE HUMAN LAMBDA FREE KIT The Binding Site Group , Ltd. DEH Class II 2014-04-16
K140664 HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS The Binding Site Group , Ltd. DEB Class II 2014-04-16
K140105 HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII The Binding Site OPX Class II 2014-03-18
K131791 IFA 40: HEP-20-10 Euroimmun US DHN Class II 2014-02-26
K133404 IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH Phadia AB DGC Class II 2014-02-24
K123880 QUANTA FLASH CENTROMERE Inova Diagnostics, Inc. LJM Class II 2014-02-07
K131330 GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT Gold Standard Diagnostics LJM Class II 2014-01-28
DEN130018 CYTOSCAN(R) DX Affymetrix, Inc. PFX Class II 2014-01-17
K130945 CALPREST Eurospital S.P.A. NXO Class II 2014-01-16
K130122 BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER Beckman Coulter, Inc. CFN Class II 2014-01-07
K131821 ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY Phadia US, Inc. MID Class II 2013-12-23
K132555 HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT The Binding Site PCN Class II 2013-12-20
K132082 AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK Aesku Diagnostics MST Class II 2013-12-05
K124006 ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY Illumina, Inc. PFR Class II 2013-11-19
K132750 ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY Illumina, Inc. PFS Class II 2013-11-19
DEN130011 ILLUMINA MISEQDX PLATFORM Illumina, Inc. PFF Class II 2013-11-19
K123713 IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA Immco Diagnostics, Inc. MVM Class II 2013-10-25
K130528 BIOPLEX 2200 APLS IGM Bio-Rad Laboratories MID Class II 2013-10-21
K130053 BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI Bio-Rad Laboratories, Inc. MVM Class II 2013-09-19
K130010 PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY Nanostring Technologies NYI Class II 2013-09-06
K122197 AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES Phadia US, Inc. DHB Class II 2013-08-28
K130268 BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY Becton, Dickinson & CO OUY Class II 2013-08-23
K131185 ANA SCREEN ELISA (IGG) Euroimmun US LJM Class II 2013-07-15
K131738 IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H Phadia AB DHB Class II 2013-07-10
K123256 HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS The Binding Site Group , Ltd. DEM Class II 2013-07-03
K123275 IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOM Phadia AB DHB Class II 2013-06-28
K130794 CELLTRACKS ANALYZER II SYSTEM Veridex, LLC NQI Class II 2013-06-20
K121045 HUMAN ALBUMIN CSF KIT The Binding Site Group , Ltd. DCF Class II 2013-06-19
K123261 EUROIMMUN ANTI-NRNP/SM ELISA (IGG) Euroimmun US LKO Class II 2013-06-12
K123785 DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET Diazyme Laboratories DDR Class II 2013-06-07
K122965 HUMAN CAERULOPLASMIN KIT The Binding Site Group , Ltd. DDB Class II 2013-06-03
K120901 HUMAN IGA CSF KIT FOR USE ON SPAPLUS The Binding Site Group , Ltd. CFN Class II 2013-05-30
K124056 FREND PSA PLUS (REAGENT CARTRIDGE) Nanoentek, Inc. LTJ Class II 2013-05-29
K120749 HUMAN IGG CSF KIT The Binding Site Group , Ltd. CFN Class II 2013-05-17
K120750 HUMAN IGM CSF KIT The Binding Site Group , Ltd. CFN Class II 2013-05-17
K122923 QUANTA FLASH ENA7 Inova Diagnostics, Inc. LLL Class II 2013-05-07
K123593 QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS, Inova Diagnostics, Inc. LKP Class II 2013-04-17
K122304 HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS The Binding Site Group , Ltd. DBA Class II 2013-04-15
K113439 EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG) Euroimmun US NIY Class II 2013-04-12
K112996 EUROIMMUN ANTI-ENA POOL ELISA (IGG) Euroimmun US LLL Class II 2013-04-09
K121576 IMMULITE 2000 ANTI-CCP IGG ASSAY Siemens Healthcare Diagnostics, Inc. NHX Class II 2013-04-04
K120056 HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER The Binding Site Group , Ltd. DFH Class II 2013-04-01
K113823 HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT The Binding Site Group , Ltd. CFN Class II 2013-03-27
K121156 AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES Phadia AB DHB Class II 2013-03-13
K120817 QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA Inova Diagnostics, Inc. MID Class II 2013-02-26
K120236 TRANSFERRIN KIT FOR USE ON THE SPAPLUS The Binding Site Group , Ltd. DDG Class II 2013-02-13
K122554 GENASIS SCANVIEW SYSTEM Applied Spectral Imaging , Ltd. NTH Class II 2013-02-07
K121463 IMMUNOCAP ALLERGEN K82 Thermo Fisher Scientific DHB Class II 2013-01-29
K122062 APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER Gen-Probe, Inc. OUY Class II 2013-01-09
K112910 AP 72OS SEMI-AUTOMATED INSTRUMENT Hitachi Chemical Diagnostics, Inc. DHB Class II 2012-12-20
K121046 STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT Kronus Market Development Associates, Inc. PCG Class II 2012-12-20
K123046 ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR Siemens Healthcare Diagnostics, Inc. DFC Class II 2012-12-20
K113377 GLIADIN IGA AND GLIADIN LGA Grifols USA, LLC MST Class II 2012-12-14
K122821 CELLTRACKS AUTOPREP SYSTEM Veridex, LLC NQI Class II 2012-12-13
K122722 COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160 Roche Diagnostics DFC Class II 2012-11-29
K113020 IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS Immco Diagnostics, Inc. MID Class II 2012-10-25
K120889 AESKUSLIDES ANA HEP-2 Aesku Diagnostics DHN Class II 2012-10-15
K122599 ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR Siemens Healthcare Diagnostics, Inc. DDR Class II 2012-10-03
K121558 DIAZYME HSCRP POC TEST KIT Diazyme Laboratories DCK Class II 2012-09-21
K113863 QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS Inova Diagnostics, Inc. MST Class II 2012-09-20
K113841 IMMUNOCAP ALLERGEN COMPONENTS BUNDLE Phadia US, Inc. DHB Class II 2012-09-13
K112223 EUROIMMUN ANTI-LKM-1 ELISA(LGG) Euroimmun US NBS Class II 2012-09-11
K112221 EUROIMMUN ANTI-SLA/LP ELISA(LGG) Euroimmun US NIY Class II 2012-09-11
K112624 ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5 Roche Diagnostics OIU Class II 2012-09-10
K122066 HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS The Binding Site Group , Ltd. JZG Class II 2012-08-30
K120169 INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT Grifols USA, LLC CFF Class II 2012-08-24
K113809 HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) Hitachi Chemical Diagnostics, Inc. DCN Class II 2012-08-17
K112545 QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM Inova Diagnostics, Inc. MOB Class II 2012-07-31
K113349 HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO The Binding Site Group , Ltd. DAE Class II 2012-07-11
K113610 ANA-SCREEN WITH MDSS Bio-Rad Laboratories LKJ Class II 2012-07-09
K111369 THE HELENA V8 IMMUNODISPLACEMENT KIT Helena Laboratories Uk, Ltd. CFF Class II 2012-06-26
K112414 ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY Phadia US, Inc. MSV Class II 2012-06-22
K111956 KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT Kronus Market Development Associates, Inc. PAF Class II 2012-05-30
K121232 K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR Kamiya Biomedical Company DBF Class II 2012-05-24
K113072 TINA-QUANT ALBUMIN GEN.2 Roche Diagnostics Operations DCF Class II 2012-05-14
K103834 BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS Bio-Rad Laboratories MID Class II 2012-03-30
K113420 RNARETAIN Asuragen, Inc. OZF Class II 2012-03-16
K103824 HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS The Binding Site CFN Class II 2012-02-27
DEN120001 IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE Phadia US, Inc. OYL Class II 2012-02-15
K110874 ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR Siemens Healthcare Diagnostics, Inc. JZG Class II 2012-01-20
K110406 CELLTRACKS AUTOPREP SYSTEM Veridex, LLC NQI Class II 2012-01-20
K112523 IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT Siemens Healthcare Diagnostics, Inc. DHB Class II 2012-01-06
K112933 ACCESS THYROGLOBULIN ANITBODY Beckman Coulter, Inc. JNL Class II 2011-12-27
K111919 IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS Phadia US, Inc. DHB Class II 2011-12-22
K102425 ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM Zeus Scientific, Inc. MID Class II 2011-12-12
K113181 CELLTRACKS ANALYER II Veridex, LLC NQI Class II 2011-12-12

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