meddevicedb.com FDA Device Reference

Review Panel

Immunology FDA 510(k) Clearances & Devices

Cleared Devices
3,548
Product Codes (page)
43
Latest Decision
2001-10-15

Clearances · page 11 of 36

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K013134 IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS) Diagnostic Products Corp. DHB Class II 2001-10-15
K013079 REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT Corgenix, Inc. MSV Class II 2001-09-28
K012795 DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM Diamedix Corp. MST Class II 2001-09-28
K012797 DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM Diamedix Corp. MST Class II 2001-09-28
K013080 REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT Corgenix, Inc. MSV Class II 2001-09-28
K013077 REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT Corgenix, Inc. MSV Class II 2001-09-28
K012901 COLOR-MONOGEN Instrumentation Laboratory CO KTN Class II 2001-09-27
K013018 REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT Corgenix, Inc. MID Class II 2001-09-20
K012393 TINA-QUANT TRANSFERRIN VER.2 Roche Diagnostics Corp. DDG Class II 2001-09-19
K012371 TINA-QUANT TRANSFERRIN VER.2 Roche Diagnostics Corp. DDG Class II 2001-09-19
K012208 ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895 Beckman Coulter, Inc. DDC Class II 2001-09-07
K012296 HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T The Binding Site, Ltd. CFN Class II 2001-08-31
K012292 HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB The Binding Site, Ltd. CFN Class II 2001-08-31
K012567 MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT Corgenix, Inc. MID Class II 2001-08-23
K012291 HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA The Binding Site, Ltd. CFN Class II 2001-08-20
K012053 DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM Diamedix Corp. MID Class II 2001-08-20
K012295 HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T The Binding Site, Ltd. CFN Class II 2001-08-20
K012163 POLYTITER SYSTEM Polymedco, Inc. DHN Class II 2001-08-20
K010796 AIA-PACK BRCA, ST AIA PACK BRCA Tosoh Medics, Inc. MOI Class II 2001-08-16
K011031 VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT Vysis MMW Class II 2001-08-03
K011662 MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL The Binding Site, Ltd. DDG Class II 2001-07-30
K011663 MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS The Binding Site, Ltd. DEM Class II 2001-07-30
K011140 QUANTA PLEX ENA PROFILE 4 Inova Diagnostics, Inc. LLL Class II 2001-07-27
K011780 K-ASSAY C1-INA Kamiya Biomedical Co. DBA Class II 2001-07-25
K003851 BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119 Biocheck, Inc. DCK Class II 2001-07-20
K011566 QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA Inova Diagnostics, Inc. MVM Class II 2001-07-09
K011570 QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA Inova Diagnostics, Inc. MVM Class II 2001-07-09
K011348 PHASE II GBM IGG ANTIBODY EIA TEST Scimedx Corp. MVJ Class II 2001-06-25
K010326 WAKO AUTOKIT C3 Wako Chemicals USA, Inc. CZW Class II 2001-06-25
K010325 WAKO AUTOKIT C4 Wako Chemicals USA, Inc. DBI Class II 2001-06-25
K011396 IBD-CHEK Techlab, Inc. DEG Class I 2001-06-18
K011082 TPO IGG ANTIBODY EIA TEST Scimedx Corp. JZO Class II 2001-06-06
K011415 ALPCO MILENIA ANTI-TG EIA American Laboratory Products Co., Ltd. JZO Class II 2001-05-30
K010597 SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT Beckman Coulter, Inc. DCK Class II 2001-05-29
K011201 ALPCO MILENIA ANTI-TPO ELISA American Laboratory Products Co., Ltd. JZO Class II 2001-05-24
K000733 QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA Inova Diagnostics, Inc. NBT Class II 2001-05-21
K010978 TINA-QUANT ALPHA-1 ANTITRYPSIN Rochdiag DEM Class II 2001-05-18
K011079 K-ASSAY HS-CRP CONTROLS Kamiya Biomedical Co. DCK Class II 2001-05-16
K010855 RANDOX IGE Randox Laboratories, Ltd. DGC Class II 2001-05-15
K003400 CRP HS TEST SYSTEM Roche Diagnostics Corp. DCN Class II 2001-05-10
K010700 RANDOX MYOGLOBIN Randox Laboratories, Ltd. DDR Class II 2001-05-08
K003064 TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323 Roche Diagnostics Corp. DDG Class II 2001-05-01
K010440 FREELITE LAMBDA FREE KIT The Binding Site, Ltd. DEH Class II 2001-04-26
K010441 FREELITE KAPPA FREE KIT The Binding Site, Ltd. DEH Class II 2001-04-26
K010550 VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428 bioMerieux, Inc. LTJ Class II 2001-04-24
K010625 EUROSPITAL EU-TTG IGA UMANA Scimedx Corp. MVM Class II 2001-04-24
K010288 ANEUVYSION MULITICOLOR DNA PROBE KIT Vysis OYU Class II 2001-04-13
K001352 REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT Corgenix, Inc. DHC Class II 2001-04-09
K010236 IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT Beckman Coulter, Inc. DCK Class II 2001-04-05
K010558 QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA Inova Diagnostics, Inc. MLE Class II 2001-04-03
K001398 REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT Corgenix, Inc. DHC Class II 2001-03-30
K010588 ELECSYSCA 15-3 II ASSAY Roche Diagnostics Corp. MOI Class II 2001-03-28
K003747 C1-INHIBITOR MICROTITER ASSAY DEVICE Baxter Healthcare Corp DBA Class II 2001-03-19
K010287 SCIMEDX PHASE II PR3 IGG ANTIBODY EIA Scimedx Corp. MOB Class II 2001-03-16
K010617 SPIFE IFE CALIBRATOR AND CONTROL KIT Helena Laboratories DEW Class II 2001-03-15
K010289 SCIMEDX PHASE II MPO IGG ANTIBODY EIA Scimedx Corp. MOB Class II 2001-03-07
K010146 ENA EIA KIT RANGE The Binding Site, Ltd. LLL Class II 2001-03-01
K010147 ENA EIA KIT The Binding Site, Ltd. LLL Class II 2001-03-01
K003963 DIMENSION PSA FLEX REAGENT CARTRIDGE Dade Behring, Inc. LTJ Class II 2001-02-28
K010148 ENA SCREEN EIA KIT The Binding Site, Ltd. LLL Class II 2001-02-23
K004019 ANA EIA DIAGNOSTIC TEST KIT The Binding Site, Ltd. LJM Class II 2001-02-15
K003419 RCRP FLEX REAGENT CARTRIDGE Dade Behring, Inc. DCN Class II 2001-02-14
K002585 RANDOX TRANSFERRIN Randox Laboratories, Ltd. DDG Class II 2001-02-05
K003669 KAPPA IMMAGE FREELITE KIT The Binding Site, Ltd. DFH Class II 2001-02-01
K003671 LAMBDA IMMAGE FREELITE KIT The Binding Site, Ltd. DEH Class II 2001-02-01
K003342 WAKO CRP-UL, CRP-UL CALIBRATOR SET Wako Chemicals USA, Inc. DCN Class II 2001-01-22
K003959 QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA Inova Diagnostics, Inc. LJM Class II 2001-01-22
K003372 IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP Diagnostic Products Corp. DCN Class II 2000-12-26
K003291 BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY Bayer Diagnostics Corp. JZO Class II 2000-12-05
K003414 VARELISA TG (THYROGLOBULIN) ANTIBODIES, Pharmacia & Upjohn Co. JZO Class II 2000-11-27
K003069 ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM Quest Intl., Inc. MID Class II 2000-11-27
K002731 N LATEX B2-MICROGLOBULIN Dade Behring, Inc. JZG Class II 2000-11-20
K002564 SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT The Binding Site, Ltd. DFH Class II 2000-10-26
K002560 SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT The Binding Site, Ltd. DGC Class II 2000-10-26
K002563 SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT The Binding Site, Ltd. DEH Class II 2000-10-26
K002376 ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY Bayer Corp. LTJ Class II 2000-10-26
K002561 SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT The Binding Site, Ltd. CZJ Class II 2000-10-26
K002918 OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT Olympus America, Inc. DCN Class II 2000-10-25
K002558 K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE Kamiya Biomedical Co. DCK Class II 2000-10-25
K003094 FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER Qualigen, Inc. LTJ Class II 2000-10-25
K001468 ELECSYS CA 15-3 TEST SYSTEM Roche Diagnostics Corp. MOI Class II 2000-10-23
K002888 NICHOLS ADVANTAGE THYROGLOB Nichols Institute Diagnostics MSW Class II 2000-10-20
K002905 ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER Beckman Coulter, Inc. MSW Class II 2000-10-19
K002189 GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM Scimedx Corp. MST Class II 2000-10-19
K002358 MDI GLIADIN A TEST Micro Detect, Inc. MST Class II 2000-10-19
K002359 MDI GLIADIN G TEST Micro Detect, Inc. MST Class II 2000-10-19
K002169 GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM Scimedx Corp. MST Class II 2000-10-19
K002651 C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET Pointe Scientific, Inc., DCK Class II 2000-10-13
K003054 AUTOSTAT II ENA-6 PROFILE ELISA Cogent Diagnotics , Ltd. LLL Class II 2000-10-13
K003057 AUTOSTAT II ENA-4 PROFILE ELISA Cogent Diagnotics , Ltd. LLL Class II 2000-10-13
K002674 RANDOX MICROALBUMIN Randox Laboratories, Ltd. DDZ Class II 2000-10-05
K002799 PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100 Beckman Coulter, Inc. CFF Class II 2000-10-05
K992228 BAYER IMMUNO 1 HER-2/NEU ASSAY Bayer Corp. NCW Class II 2000-09-29
K994112 MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA) Oncogene Science, Inc. NCW Class II 2000-09-29
K002215 AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA Cogent Diagnotics , Ltd. MOB Class II 2000-09-28
K001647 BN PROSPEC SYSTEM Dade Behring, Inc. JZW Class I 2000-09-26
K001022 BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 Biocheck, Inc. JZG Class II 2000-09-26
K002559 EL-ANA PROFILES-2K1 Theratest Laboratories, Inc. LJM Class II 2000-09-12
K001900 ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST Helix Diagnostics, Inc. LRM Class II 2000-09-11
K002609 TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM Roche Diagnostics Corp. DHR Class II 2000-09-05

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