Review Panel
Immunology FDA 510(k) Clearances & Devices
- Cleared Devices
- 3,548
- Product Codes (page)
- 52
- Latest Decision
- 2009-04-27
Clearances · page 6 of 36
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K090236 | DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454 | Siemens Healthcare Diagnostics | LOJ | Class II | 2009-04-27 |
| K082085 | CAPILLARYS IMMUNOTYPING, MODEL 2100 | Sebia | CFF | Class II | 2009-04-17 |
| K083381 | EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG) | Euroimmun Us, Inc. | LRM | Class II | 2009-04-15 |
| K082388 | MINICAP IMMUNOTYPING, MODEL: 2300 | Sebia | CFF | Class II | 2009-04-14 |
| K080561 | VIDAS CA 125 II ASSAY | bioMerieux, Inc. | LTK | Class II | 2009-04-10 |
| K082759 | ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY | Phadia US, Inc. | LKJ | Class II | 2009-04-10 |
| K082251 | SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100 | Beckman Coulter, Inc. | DCF | Class II | 2009-04-08 |
| K082130 | EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG) | Euroimmun Us, Inc. | MOB | Class II | 2009-04-07 |
| K083445 | N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC | Siemens Healthcare Diagnostics | CFN | Class II | 2009-03-24 |
| K083853 | IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT | Siemens Healthcare Diagnostics | DHB | Class II | 2009-03-24 |
| K083444 | C-REACTIVE PROTEIN (LATEX) | Roche Diagnostics Corp. | DCN | Class II | 2009-03-18 |
| K081615 | OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN | Olympus America, Inc. | DHX | Class II | 2009-03-18 |
| K083615 | EUROIMMUN ANTI BP 180-4X ELISA (IGG) | Euroimmun Us, Inc. | OEG | Class II | 2009-03-16 |
| K081709 | OLYMPUS AFP - ALPHA-FETOPROTEIN | Olympus Life Science Research Europa GmbH (Europa) | LOJ | Class II | 2009-03-16 |
| K081830 | IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID READER CHECK DEVICE, AND IMMUNOCAP RAPID QC1 | Phadia AB | DHB | Class II | 2009-03-16 |
| K083463 | DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M | Siemens Healthcare Diagnostics | JZG | Class II | 2009-03-13 |
| K083188 | VARELISA RECOMBI ANA SCREEN, MODEL 12 596 | Phadia US, Inc. | LJM | Class II | 2009-03-13 |
| K083314 | IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT | Siemens Healthcare Diagnostics | DHB | Class II | 2009-03-11 |
| K083412 | PATHFAST HSCRP | Mitsubishi Kagaku Iatron | DCN | Class II | 2009-03-09 |
| K080481 | ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS | Beckman Coulter, Inc. | DDR | Class II | 2009-02-20 |
| K082129 | HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER | The Binding Site, Ltd. | CFN | Class II | 2009-02-10 |
| K082150 | MODIFICATION TO PAXGENE BLOOD RNA SYSTEM | Preanalytix GmbH | NTW | Class II | 2009-02-04 |
| K083040 | S-TEST C-REACTIVE PROTEIN (CRP) | Alfa Wassermann Diagnostic Technologies, Inc. | DCN | Class II | 2009-01-30 |
| K082488 | DIAZYME LP(A) ASSAY | General Atomics | DFC | Class II | 2009-01-13 |
| K082503 | DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL | Siemens Healthcare Diagnostics | DFH | Class II | 2008-12-19 |
| K081827 | HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS | The Binding Site, Ltd. | CFN | Class II | 2008-12-19 |
| K071474 | DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426 | Siemens Healthcare Diagnostics | NTV | Class II | 2008-12-10 |
| K081248 | QUANTA LITE OMP PLUS ELISA | Inova Diagnostics, Inc. | OKM | Class II | 2008-10-27 |
| K080909 | ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000 | Ikonisys, Inc. | NTH | Class II | 2008-10-17 |
| K081674 | BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG) | The Binding Site, Ltd. | MST | Class II | 2008-10-15 |
| K080194 | VIDAS CEA (S) ASSAY | bioMerieux, Inc. | DHX | Class II | 2008-10-09 |
| K080017 | VIDAS AFP ASSAY | bioMerieux, Inc. | LOJ | Class II | 2008-09-26 |
| K081338 | ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP | Roche Diagnostics | NHX | Class II | 2008-09-11 |
| K071961 | MESACUP MODELS BP180 AND BP230 ELISA KITS | Mbl International Corporation | OEG | Class II | 2008-08-25 |
| K080634 | ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495 | Beckman Coulter, Inc. | DDG | Class II | 2008-08-11 |
| K081299 | DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA | Siemens Healthcare Diagnostics, Inc. | DDG | Class II | 2008-08-08 |
| K081294 | ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS | Siemens Healthcare Diagnostics, Inc. | NQD | Class II | 2008-07-29 |
| K080092 | ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB | Roche Diagnostics Corp. | JZO | Class II | 2008-07-28 |
| K081161 | DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST | Dade Behring, Inc. | CFN | Class II | 2008-07-28 |
| K081249 | DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM | Dade Behring, Inc. | DEB | Class II | 2008-07-21 |
| K080252 | MODIFICATION TO MAMMAPRINT | Agendia BV | NYI | Class II | 2008-07-21 |
| K080916 | CAPILLARYS URINE | Sebia | JKM | Class II | 2008-07-01 |
| K072901 | AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101 | Amdl, Inc. | NTY | Class II | 2008-07-01 |
| K071603 | DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) | Dade Behring, Inc. | DHX | Class II | 2008-06-25 |
| K080523 | KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT | Kronus Market Development Associates, Inc. | NST | Class II | 2008-06-17 |
| K072939 | HE4 EIA, MODEL: 404-10 US | Fujirebio Diagnostics,Inc. | OIU | Class II | 2008-06-09 |
| K071597 | DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600 | Dade Behring, Inc. | LOJ | Class II | 2008-06-04 |
| K081217 | HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM | Hycor Biomedical, Inc. | DHB | Class II | 2008-05-22 |
| K080159 | KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT | Kronus Market Development Associates, Inc. | JZO | Class II | 2008-05-22 |
| K081251 | MODIFICATION TO AESKULISA DS DNA G | Aesku Diagnostics | LSW | Class II | 2008-05-13 |
| K081104 | AESKULISA ANA HEP-2, REF 30-7115US | Aesku Diagnostics | LKJ | Class II | 2008-05-02 |
| K073590 | KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT | Kronus Market Development Associates, Inc. | OIF | Class II | 2008-04-10 |
| K072032 | IGG ANTI-ATHEROX TEST KIT | Corgenix, Inc. | MSV | Class II | 2008-04-04 |
| K072658 | ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS | Siemens Medical Solutions Diagnostics | DCN | Class II | 2008-04-01 |
| K063787 | INPLEX CF MOLECULAR TEST | Third Wave Technologies, Inc. | NUA | Class II | 2008-03-13 |
| K073277 | ROCHE-CREACTIVE PROTEIN (LATEX) | Roche Diagnostics Corp. | DCN | Class II | 2008-03-06 |
| K080322 | HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200 | Hycor Biomedical, Inc. | DHB | Class II | 2008-03-05 |
| K072944 | QUANTA LITE CCP3.1 IGG/IGA ELISA | Inova Diagnostics, Inc. | NHX | Class II | 2008-03-05 |
| K073561 | DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR | Dade Behring, Inc. | CFN | Class II | 2008-02-26 |
| K073338 | CELLSEARCH CIRCULATING TUMOR CELL KIT | Veridex, LLC | NQI | Class II | 2008-02-26 |
| K073145 | QUANTA LITE H-TTG SCREEN | Inova Diagnostics, Inc. | MVM | Class II | 2008-02-12 |
| K073489 | OLYMPUS IGA REAGENT | Olympus America, Inc. | CFN | Class II | 2008-02-11 |
| K073487 | OLYMPUS IGM REAGENT | Olympus America, Inc. | CFN | Class II | 2008-02-11 |
| K073490 | OLYMPUS IGG REAGENT | Olympus America, Inc. | CFN | Class II | 2008-02-11 |
| K072632 | QUANTA PLEX CELIAC IGG PROFILE | Inova Diagnostics, Inc. | MVM | Class II | 2008-02-11 |
| K072889 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER | The Binding Site, Ltd. | CFN | Class II | 2008-02-01 |
| K072967 | QUANTA LITE F-ACTIN IGA ELISA | Inova Diagnostics, Inc. | MVM | Class II | 2008-01-28 |
| K072149 | ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 | Phadia US, Inc. | LLL | Class II | 2008-01-15 |
| K070789 | EUROIMMUN ANTI-CCP ELISA | Euroimmun Us, LLC | NHX | Class II | 2007-12-31 |
| K072965 | DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON | Dade Behring, Inc. | DBA | Class II | 2007-12-21 |
| K070458 | MODIFICATION TO FIDIS VASCULITIS, MODEL MX007 | Biomedical Diagnostics (Bmd) SA | MOB | Class II | 2007-12-21 |
| K070486 | CAPILLARYS URINE (PN 2012) | Sebia, Inc. | JKM | Class II | 2007-12-21 |
| K072599 | PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109 | Diadexus, Inc. | NOE | Class II | 2007-12-20 |
| K071210 | MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006 | Biomedical Diagnostics (Bmd) SA | LKO | Class II | 2007-12-19 |
| K072078 | QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 | Biokit, S.A. | JZG | Class II | 2007-12-19 |
| K072393 | ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01 | Phadia US, Inc. | LSW | Class II | 2007-12-07 |
| K071219 | ATHENA MULTI-LYTE GBM TEST SYSTEM | Zeus Scientific, Inc. | MVJ | Class II | 2007-12-06 |
| K071712 | LEUKO EZ VUE | Techlab Inc., Corporate Research Center | DEG | Class I | 2007-12-04 |
| K070900 | FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT | The Binding Site, Ltd. | DFH | Class II | 2007-11-30 |
| K072661 | IMMUNOCAP THYRLOBULIN IMMUNOCAP | Phadia US, Inc. | JNL | Class II | 2007-11-20 |
| K071729 | CELLSEARCH CIRCULATING TUMOR CELL KIT | Veridex, LLC | NQI | Class II | 2007-11-20 |
| K071711 | ASCA-CHEK | Techlab Inc., Corporate Research Center | NBT | Class II | 2007-11-07 |
| K072135 | KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT | Kronus Market Development Associates, Inc. | NWG | Class II | 2007-11-07 |
| K072794 | IMMULITE 2500 OM-MA, MODEL L5KOP | Siemens Medical Solutions Diagnostics | LTK | Class II | 2007-11-05 |
| K071692 | THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS | Theratest Laboratories, Inc. | MVM | Class II | 2007-11-05 |
| K072358 | BIOPLEX VASCULITIS KIT | Bio-Rad Laboratories | MVJ | Class II | 2007-10-31 |
| K072612 | ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647 | Beckman Coulter, Inc. | MOI | Class II | 2007-10-26 |
| K063838 | LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH | Thermo Electron OY | DFC | Class II | 2007-09-27 |
| K062028 | CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01 | Celera Diagnostics | NUA | Class II | 2007-09-07 |
| K071913 | IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01 | Phadia AB | DHB | Class II | 2007-08-24 |
| K063086 | TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS | Thermo Electron OY | DDG | Class II | 2007-08-08 |
| K071247 | N LATEX RF KIT | Dade Behring, Inc. | DHR | Class II | 2007-08-08 |
| K070183 | KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT | Kronus Market Development Associates, Inc. | OCN | Class II | 2007-07-13 |
| K062981 | I-CHROMA CRP TEST | Boditech Diagnostics, Inc. | DCN | Class II | 2007-07-13 |
| K070675 | MAMMAPRINT | Agendia BV | NYI | Class II | 2007-06-22 |
| K071002 | IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT | Beckman Coulter, Inc. | NQD | Class II | 2007-06-21 |
| K062372 | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER | The Binding Site, Ltd. | DFH | Class II | 2007-06-21 |
| K063818 | QUANTA PLEX CELIAC IGA PROFILE | Inova Diagnostics, Inc. | MVM | Class II | 2007-06-20 |
| K063498 | HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356) | Sebia | OBZ | Class II | 2007-06-11 |
| K070763 | EUROIMMUN ANA IFA: HEP-20-10 | Euroimmun Us, LLC | DHN | Class II | 2007-05-22 |
3,548 clearances in the Immunology panel. Data: openFDA.