meddevicedb.com FDA Device Reference

Review Panel

Immunology FDA 510(k) Clearances & Devices

Cleared Devices
3,548
Product Codes (page)
44
Latest Decision
2004-03-04

Clearances · page 9 of 36

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K040200 MESACUP-2 TEST CENP-B Rhigene, Inc. LJM Class II 2004-03-04
K033802 ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM Zeus Scientific, Inc. DHR Class II 2004-02-27
K040101 MODIFICATION TO DIADEXUS PLAC TEST Diadexus, Inc. NOE Class II 2004-02-05
K033036 BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647 Beckman Coulter, Inc. MOI Class II 2004-02-03
K033811 FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER The Binding Site, Ltd. DEH Class II 2004-01-30
K032692 DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 Dako A/S JZG Class II 2004-01-22
K033982 MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST Vysis MMW Class II 2004-01-22
K033908 N HIGH SENSITIVITY CRP Dade Behring, Inc. NQD Class II 2004-01-22
DEN040001 CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM Advanced Diagnostic Systems NQI Class II 2004-01-21
K033744 AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA Hycor Biomedical , Ltd. MVM Class II 2004-01-20
K032796 IBL C3D-CIC EIA TEST Ibl GmbH CZW Class II 2004-01-13
K033525 DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114 Dade Behring, Inc. DCF Class II 2004-01-12
K034013 REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 Corgenix, Inc. LKJ Class II 2004-01-08
K033038 GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688 Beckman Coulter, Inc. NIG Class II 2003-12-29
K032571 IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA Immco Diagnostics, Inc. MVM Class II 2003-12-24
K033528 MESACUP-2 TEST JO-1, MODEL 10756 Rhigene, Inc. LLL Class II 2003-12-22
K032663 QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2 Instrumentation Laboratory CO DCK Class II 2003-12-19
K032251 IMMUNETECH TOTAL IGE SYSTEM Immunetech Corporation DGC Class II 2003-12-19
K032469 AESKULISA ANA 8PRO Aesku, Inc. LLL Class II 2003-12-16
K033187 INTERLAB IMMUNOFIXATION TEST(S) Interlab S.R.L. CFF Class II 2003-11-19
K033300 VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS Ortho-Clinical Diagnostics, Inc. DDR Class II 2003-11-05
K033277 HYDRAGEL CSF ISOFOCUSING KITS Morax CFF Class II 2003-11-04
K032868 REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139 Corgenix, Inc. MID Class II 2003-10-14
K031607 ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL Orion Diagnostica, Div. Orion Corp. DCK Class II 2003-10-10
K030044 EXTENDED RANGE HS CRP KIT, CAT NO:9200 Reference Diagnostics, Inc. DCK Class II 2003-09-30
K032240 BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT The Binding Site, Ltd. MID Class II 2003-09-29
K031308 RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 Rhigene, Inc. DBM Class II 2003-09-26
K032535 MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM Roche Diagnostics Corp. DHR Class II 2003-09-10
K031563 BINDAZYME CLQ CIC EIA KIT The Binding Site, Ltd. DAK Class II 2003-09-10
K032134 TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT Kronus Market Development Associates, Inc. JZO Class II 2003-09-10
K030702 IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA Immco Diagnostics, Inc. MSV Class II 2003-09-09
K030701 IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA Immco Diagnostics, Inc. MSV Class II 2003-09-09
K031857 ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY Bayer Diagnostics Corp. DEM Class II 2003-09-04
K032254 IBL C1Q-CIC CIA TEST Ibl GmbH DAK Class II 2003-08-29
K032014 N LATEX IGM Dade Behring, Inc. CFN Class II 2003-08-07
K032035 SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI Beckman Coulter, Inc. CZW Class II 2003-08-07
K032336 TINA-QUANT CRP (LATEX) Roche Diagnostics Corp. DCN Class II 2003-08-05
K030477 DIADEXUS PLAC TEST Diadexus, Inc. NOE Class II 2003-07-18
K031650 FERRITIN GENERATION 2 Roche Diagnostics Corp. DBF Class II 2003-07-17
K031016 FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II The Binding Site, Ltd. DEH Class II 2003-07-15
K031208 REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001 Corgenix, Inc. MSV Class II 2003-07-07
K030899 C-REACTIVE PROTEIN (CRP) Abbott Laboratories DCN Class II 2003-07-02
K031450 QUANTA PLEX ENA PROFILE 6 Inova Diagnostics, Inc. LLL Class II 2003-06-25
K031393 BAYER ADVIA CENTAUR CA 19-9 ASSAY Bayer Healthcare, LLC NIG Class II 2003-06-24
K031177 DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M Axis-Shield Diagnostics, Ltd. MSV Class II 2003-06-19
K024280 WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET Wako Chemicals USA, Inc. DCK Class II 2003-06-06
K030545 CRP-LATEX (II)X2 SEIKEN ASSAY KIT Denka Seiken Co., Ltd. DCK Class II 2003-06-02
K031343 TPSA FLEX REAGENT CARTRIDGE Dade Behring, Inc. LTJ Class II 2003-05-15
K030775 AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM Immuno Concepts, N.A. , Ltd. LKJ Class II 2003-05-12
K031270 ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS Beckman Coulter, Inc. DHX Class II 2003-05-06
K031269 ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS Beckman Coulter, Inc. MSW Class II 2003-05-02
K031297 ACCESS OV MONITOR ASSAY Beckman Coulter, Inc. LTK Class II 2003-05-02
K030929 ANA DETECT Orgentec Diagnostika GmbH LJM Class II 2003-05-02
K030741 AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA Hycor Biomedical , Ltd. MID Class II 2003-05-01
K023860 MICROALBUMIN REAGENT SET AND CALIBRATORS Pointe Scientific, Inc., DDZ Class II 2003-04-28
K030681 QUANTA PLEX ENA PROFILE 5 Inova Diagnostics, Inc. LLL Class II 2003-04-24
K030704 IBD-QUIK CHEK Techlab, Inc. DEG Class I 2003-04-21
K030238 BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT The Binding Site, Ltd. DBM Class II 2003-03-24
K030590 CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82) Hitachi Chemical Diagnostics, Inc. DHB Class II 2003-03-21
K030397 AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA Hycor Biomedical , Ltd. MSV Class II 2003-03-21
K030626 VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7 Ortho-Clinical Diagnostics, Inc. DCK Class II 2003-03-18
K024210 IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR Beckman Coulter, Inc. DGC Class II 2003-02-24
K030215 BIORAPID MONONUCLEOSIS Instrumentation Laboratory CO KTN Class II 2003-02-24
K024162 SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 Helena Laboratories CFF Class II 2003-02-19
K024038 N LATEX IGA Dade Behring, Inc. CZP Class II 2003-02-13
K024031 THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE Theratest Laboratories, Inc. LJM Class II 2003-02-06
K024151 EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P Theratest Laboratories, Inc. MQA Class II 2003-02-06
K023593 SERAQUEST ANTI-THYROID PEROXIDASE (TPO) Quest Intl., Inc. JZO Class II 2003-02-06
K030124 OLYMPUS FERRITIN REAGENT Olympus America, Inc. DBF Class II 2003-02-06
K023828 K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR Kamiya Biomedical Co. DCK Class II 2003-02-04
K024017 BAYER ADVIA CENTAUR HER-2/NEU ASSAY Bayer Corp. NCW Class II 2003-01-30
K023131 FREELITE HUMAN LAMBDA FREE KIT The Binding Site, Ltd. DEH Class II 2003-01-21
K023009 FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZER The Binding Site, Ltd. DFH Class II 2003-01-21
K024220 LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130 Bio-Rad DHN Class II 2003-01-17
K024218 LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 Bio-Rad LKJ Class II 2003-01-17
K024232 LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113 Bio-Rad LKJ Class II 2003-01-17
K024067 RHEUMATOID FACTOR (RF) Abbott Laboratories DHR Class II 2003-01-15
K024224 LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129 Bio-Rad DHN Class II 2003-01-15
K024222 LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112 Bio-Rad DHN Class II 2003-01-15
K024219 LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115 Bio-Rad LKP Class II 2003-01-15
K024230 LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEOLAR PATTERNS, CATALOG #131 Bio-Rad DHN Class II 2003-01-15
K024227 LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127 Bio-Rad DHN Class II 2003-01-15
K024217 LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108 Bio-Rad DHN Class II 2003-01-15
K024229 LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #111 Bio-Rad DHN Class II 2003-01-15
K024221 LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118 Bio-Rad DHN Class II 2003-01-15
K024225 LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119 Bio-Rad DHN Class II 2003-01-15
K024231 LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118 Bio-Rad DHN Class II 2003-01-13
K024223 LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116 Bio-Rad LKJ Class II 2003-01-13
K024226 LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116 Bio-Rad LKJ Class II 2003-01-10
K023592 SERAQUEST ANTI-THYROGLOBULIN Quest Intl., Inc. DDC Class II 2003-01-06
K024196 REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT Corgenix, Inc. MID Class II 2003-01-03
K024195 MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT Corgenix, Inc. MID Class II 2003-01-03
K023239 AIA-PACK CA 19-9 Tosoh Corp. NIG Class II 2002-12-23
K023269 HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS Instrumentation Laboratory CO DCK Class II 2002-12-23
K022690 PAROS CRP Horiba, Ltd. DCN Class II 2002-12-23
K023240 ST AIA-PACK CA 19-9 Tosoh Corp. NIG Class II 2002-12-23
K023893 ST AIA-PACK CEA ENZYME IMMUNOASSAY Tosoh Medics, Inc. DHX Class II 2002-12-18
K022944 AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA Hycor Biomedical, Inc. MSV Class II 2002-12-18
K022945 AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA Hycor Biomedical, Inc. MSV Class II 2002-12-18
K023894 ST AIA-PACK AFP ENZYME IMMUNOASSAY Tosoh Medics, Inc. LOJ Class II 2002-12-17

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