meddevicedb.com FDA Device Reference

Review Panel

Immunology FDA 510(k) Clearances & Devices

Cleared Devices
3,548
Product Codes (page)
51
Latest Decision
2005-09-06

Clearances · page 8 of 36

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K051915 FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER The Binding Site, Ltd. DFH Class II 2005-09-06
K051564 OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH Olympus America, Inc. NQD Class II 2005-08-22
K052082 FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 Beckman Coulter, Inc. JMG Class II 2005-08-19
K050493 QUANTIA IGE Biokit, S.A. DGC Class II 2005-08-16
K050613 QUANTIA BETA-2 MICROGLOBULIN Biokit, S.A. JZG Class II 2005-08-16
K050836 CRP DIAGNOSTIC ASSAY Sentinel Ch. Srl DCK Class II 2005-08-08
K051890 ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO Roche Diagnostics Corp. JZO Class II 2005-08-04
K042579 BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT The Binding Site NBT Class II 2005-07-28
K051191 DCL MICROALBUMIN ASSAY, MODEL 252-20 Diagnostic Chemicals , Ltd. DCF Class II 2005-07-05
K050967 VARELISA RECOMBI CTD SCREEN, MODEL 13096 Sweden Diagnostics (Germany) GmbH LJM Class II 2005-06-28
K042939 CAPILLARY'S IMMUNOTYPING (PN 2100) Sebia, Inc. DFH Class II 2005-06-27
K050523 DIADEXUS PLAC TEST Diadexus, Inc. NOE Class II 2005-06-15
K050662 QUANTA LITE SP100 ELISA Inova Diagnostics, Inc. NUM Class II 2005-06-13
K051218 MODIFICATION TO: UNICAP SPECIFIC IGE Pharmacia Diagnostics AB DHB Class II 2005-06-09
K050713 DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511 Good Biotech Corp. DCN Class II 2005-06-06
K042644 AESKULISA TTG A AND AESKULISA TTG G Aesku, Inc. MVM Class II 2005-06-01
K043067 ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400 Bioarray Solutions, Ltd. LLL Class II 2005-05-31
DEN050002 LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS Wako Chemicals USA, Inc. NSF Class II 2005-05-19
K050596 QUANTIA A1-AT Biokit, S.A. DEM Class II 2005-05-13
K050715 QUANTA PLEX ANCA PROFILE Inova Diagnostics, Inc. MOB Class II 2005-05-12
K050029 CARDIOMPO TEST Prognostix, Inc. NTV Class II 2005-05-10
DEN050004 TAG-IT CYSTIC FIBROSIS KIT Tm Bioscience Corporation NUA Class II 2005-05-09
K050119 PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT Beckman Coulter, Inc. JKM Class II 2005-05-06
K050665 N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) Dade Behring, Inc. CZW Class II 2005-05-02
K050625 VARELISA RECOMBI ANA PROFILE, MODEL 18496 Sweden Diagnostics (Germany) GmbH LJM Class II 2005-04-26
K050487 QUANTIA LA(A) Biokit, S.A. DFC Class II 2005-04-26
K043519 ARIOL HER-2/NEU FISH Applied Imaging Corp. NTH Class II 2005-04-25
K050576 MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H Good Biotech Corp. DDZ Class II 2005-04-21
DEN050003 PAXGENE BLOOD RNA SYSTEM Preanalytix GmbH NTW Class II 2005-04-18
K050245 CELLSEARCH CIRCULATING TUMOR CELL KIT Veridex, LLC NQI Class II 2005-03-15
K050145 CELLTRACKA ANALYZER II Immunicon Corp. NQI Class II 2005-03-15
K043433 AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA Hycor Biomedical , Ltd. MVM Class II 2005-03-07
K042272 ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) ACON Laboratories, Inc. KTN Class II 2005-02-28
K042735 N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) Dade Behring, Inc. CFN Class II 2005-02-15
K050113 TINA-QUANT IGG GEN.2 Roche Diagnostics Corp. DEW Class II 2005-02-08
K042924 ARCHITECT STAT MYO IMMUNOASSAY Fisher Diagnostics DDR Class II 2005-01-24
K042542 CYTOVISION FOR CEP XY Applied Imaging Corp. NTH Class II 2005-01-10
K042732 ARCHITECT CA 15-3 ASSAY Fujirebio Diagnostics,Inc. MOI Class II 2004-12-22
K042982 QUANTEX MYOGLOBIN Instrumentation Laboratory CO DDR Class II 2004-12-22
K041658 BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200 Bio-Rad Laboratories, Inc. LKJ Class II 2004-12-20
K042248 KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT Kronus Market Development Associates, Inc. NST Class II 2004-12-17
DEN040010 VYSIS AUTOVYSION SYSTEM Vysis NTH Class II 2004-12-13
K042241 K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C Kamiya Biomedical Co. DGC Class II 2004-12-10
K042629 VARELISA SM ANTIBODIES, MODEL 18296 Sweden Diagnostics (Germany) GmbH LKP Class II 2004-12-08
K042152 BINDING SITE IGG SUBLCASS OLYMPUS KITS The Binding Site CFN Class II 2004-11-22
K042680 RHIGENE HEP-ANA TEST SYSTEM Corgenix, Inc. DHN Class II 2004-11-19
K042477 VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUCTS PROTEIN Ortho-Clinical Diagnostics, Inc. DDG Class II 2004-11-19
K042731 ARCHITECT CA 125 II ASSAY Fujirebio Diagnostics,Inc. LTK Class II 2004-11-19
K042643 VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II Ortho-Clinical Diagnostics, Inc. DCF Class II 2004-11-18
K042475 VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS; VITROS CHEMISTRY PRODUCT CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUC Ortho-Clinical Diagnostics, Inc. CFN Class II 2004-11-10
K041891 MININEPH HUMAN RHEUMATOID FACTOR KIT The Binding Site DHR Class II 2004-11-05
K042485 TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE) Roche Diagnostics Corp. NQD Class II 2004-10-29
K041102 IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA Immco Diagnostics, Inc. LJM Class II 2004-10-26
K042071 IBD-SCAN Techlab, Inc. DEG Class I 2004-10-20
K042494 VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III Ortho-Clinical Diagnostics CZW Class II 2004-10-19
K041155 WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY Stanbio Laboratory DCK Class II 2004-10-14
K041628 AESKULISA DS DNA G Aesku Diagnostics LSW Class II 2004-10-14
K042416 ATHENA MULTI-LYTE ANA-II TEST SYSTEM Zeus Scientific, Inc. LKJ Class II 2004-10-08
K041002 FIDIS CELIAC Biomedical Diagnostics S.A. MST Class II 2004-09-24
K042442 QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE Orion Diagnostica, OY DCK Class II 2004-09-24
K041863 VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS Ortho-Clinical Diagnostics, Inc. DHR Class II 2004-09-20
K041799 VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 17, VITROS CHEMISTRY PRODUCTS FS Ortho-Clinical Diagnostics, Inc. NQD Class II 2004-08-25
K041668 OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT Olympus America, Inc. NQD Class II 2004-08-19
K041357 VARELISA GLIADIN IGG ANTIBODIES Sweden Diagnostics (Germany) GmbH MST Class II 2004-08-02
K041173 CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996 Sweden Diagnostics (Germany) GmbH MVM Class II 2004-08-02
K041174 CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196 Sweden Diagnostics (Germany) GmbH MVM Class II 2004-07-19
K040466 BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS The Binding Site MVM Class II 2004-07-16
K041354 VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896 Sweden Diagnostics (Germany) GmbH MST Class II 2004-07-16
K041753 AESKULISA ENA 6 S Aesku Diagnostics LLL Class II 2004-07-14
K041043 VARELISA PR3 ANCA, MODEL NUMBER 17748/17796 Pharmacia Deutschland GmbH MOB Class II 2004-07-02
K040885 QUANTA LITE GP210 ELISA Inova Diagnostics, Inc. NRI Class II 2004-06-25
K040241 N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET Genzyme Corp. DCK Class II 2004-06-25
K040953 AESKULISA ANA HEP-2 Aesku, Inc. LJM Class II 2004-06-23
K040579 CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) Cholestech Corp. DCK Class II 2004-06-18
K041322 VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS Ortho-Clinical Diagnostics, Inc. DHX Class II 2004-06-17
K040030 BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 Biocheck, Inc. DCN Class II 2004-06-16
K041040 VARELISA MPO ANCA, MODEL 17648/17696 Sweden Diagnostics (Germany) GmbH MOB Class II 2004-06-16
K040810 VARELISA HISTONE ANTIBODIES, MODEL 16496 Pharmacia Deutschland GmbH LJM Class II 2004-05-14
K040811 VARELISA SSDNA ANTIBODIES, MODEL 14896 Pharmacia Deutschland GmbH LRM Class II 2004-05-13
K040463 AESKULISA CARDIOLIPIN AGM Aesku, Inc. MID Class II 2004-05-12
K040450 VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996 Pharmacia Deutschland GmbH MSV Class II 2004-05-11
K040449 VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796 Pharmacia Deutschland GmbH MSV Class II 2004-05-11
K040451 VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896 Pharmacia Deutschland GmbH MSV Class II 2004-05-11
K040452 VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096 Pharmacia Deutschland GmbH MSV Class II 2004-05-11
K040879 QUANTEX FERRITIN Instrumentation Laboratory CO DBF Class II 2004-05-10
K040111 ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM Zeus Scientific, Inc. MOB Class II 2004-04-05
K040711 MESACUP TEST PR-3 Rhigene, Inc. MOB Class II 2004-04-02
K040586 MESACUP TEST MPO, MODEL 11053 Rhigene, Inc. MOB Class II 2004-03-22
K033454 BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN Brahms Diagnostica, LLC JZO Class II 2004-03-22
K033977 ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM Zeus Scientific, Inc. JZO Class II 2004-03-22
K032850 IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG) Immco Diagnostics, Inc. NBT Class II 2004-03-18
K032860 IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA) Immco Diagnostics, Inc. NBT Class II 2004-03-18
K040009 FREELITE HUMAN KAPPA AND LAMBDA KITS The Binding Site, Ltd. DFH Class II 2004-03-11
K040291 EL-ANA PROFILES: ANTI-CHROMATIN Theratest Laboratories, Inc. LJM Class II 2004-03-11
K040431 ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2 Roche Diagnostics Corp. DAO Class II 2004-03-10
K040435 ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 Roche Diagnostics Corp. CZP Class II 2004-03-10
K040434 ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 Roche Diagnostics Corp. DEW Class II 2004-03-10
K034057 LACRYTEST Adiatec SA DGC Class II 2004-03-09
K040160 QUANTA PLEX SLE PROFILE 8 Inova Diagnostics, Inc. LLL Class II 2004-03-08
K040095 IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA Immco Diagnostics, Inc. MVM Class II 2004-03-05

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