meddevicedb.com FDA Device Reference

Review Panel

Immunology FDA 510(k) Clearances & Devices

Cleared Devices
3,548
Product Codes (page)
39
Latest Decision
2002-12-17

Clearances · page 10 of 36

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K022177 PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM Bayer Diagnostics Corp. LTJ Class II 2002-12-17
K023152 IMMULITE 2000 ALLERGEN-SPECIFIC IGE Diagnostic Products Corp. DHB Class II 2002-12-17
K022288 COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM Bayer Corp. LTJ Class II 2002-12-17
K023853 K-ASSAY LP(A) CONTROLS Kamiya Biomedical Co. DFC Class II 2002-12-13
K023597 ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY Beckman Coulter, Inc. LTK Class II 2002-12-11
K023891 ST AIA-PACK CA 125 ENZYME IMMUNOASSAY Tosoh Medics, Inc. LTK Class II 2002-12-06
K022176 ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257 Orion Diagnostica, Div. Orion Corp. DCK Class II 2002-12-03
K022329 CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM Bayer Diagnostics Corp. LTK Class II 2002-11-27
K022800 VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM Hyperion, Inc. DHN Class II 2002-11-25
K023433 VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896 Pharmacia Diagnostics GmbH & Co. KG MID Class II 2002-11-13
K022178 CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM Bayer Diagnostics Corp. MOI Class II 2002-11-12
K023368 TRUCATH.IP Aortech Critical Care , Ltd. DFG Class II 2002-10-28
K023285 DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA Axis-Shield Diagnostics, Ltd. NHX Class II 2002-10-09
K020807 AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM Bayer Diagnostics Corp. LOJ Class II 2002-10-01
K022992 REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001 Corgenix, Inc. MID Class II 2002-09-25
K022990 REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001 Corgenix, Inc. MID Class II 2002-09-25
K021648 QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA Inova Diagnostics, Inc. NJF Class II 2002-09-20
K021057 BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS Brahms Diagnostica, LLC MSW Class II 2002-09-17
K022067 CONVOY ADVANCED DELIVERY SHEATH Boston Scientific DBY Class I 2002-09-11
K020972 WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET Wako Chemicals USA, Inc. DHR Class II 2002-09-09
K021398 APL IGA ELISA KIT Louisville Apl Diagnostics, Inc. MID Class II 2002-08-27
K014270 MININEPH HUMAN B2-MICROGLOBULIN KIT The Binding Site, Ltd. JZG Class II 2002-08-15
K022017 RHIGENE MESACUP-2 TEST RNP, MODEL M7741 Rhigene, Inc. LKO Class II 2002-08-14
K022486 K-ASSAY HS-CRP CONTROLS Kamiya Biomedical Co. DCK Class II 2002-08-14
K020672 ELECSYS ANTI-TG TEST SYSTEM Roche Diagnostics Corp. JZO Class II 2002-08-05
K021231 NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT Matritech, Inc. MMW Class II 2002-07-30
K021482 QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA Inova Diagnostics, Inc. NIY Class II 2002-07-30
K021757 CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET Good Biotech Corp. DCN Class II 2002-07-29
K013263 FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST Fred Hutchinson Cancer Research Center LKP Class II 2002-07-29
K021194 RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM Hemagen Diagnostics, Inc. DCK Class II 2002-07-29
K021660 K-ASSAY LP(A) ASSAY Kamiya Biomedical Co. DFC Class II 2002-07-25
K020828 CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM Bayer Corp. LTK Class II 2002-07-24
K021516 DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200 Axis-Shield Diagnostics, Ltd. NHX Class II 2002-07-23
K021572 SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON SYSTEMS CX C-RP CALIBRATOR Beckman Coulter, Inc. DCN Class II 2002-07-19
K022083 HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER The Binding Site, Ltd. CFN Class II 2002-07-16
K021610 QAB2A IGM ELISA KIT HRP Cheshire Diagnostics , Ltd. MSV Class II 2002-07-12
K021611 QAB2A IGG ELISA KIT HRP Cheshire Diagnostics , Ltd. MSV Class II 2002-07-12
K021882 CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510 Good Biotech Corp. DCN Class II 2002-07-11
K021394 DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM Diamedix Corp. DHR Class II 2002-07-09
K022018 RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560 Rhigene, Inc. LJM Class II 2002-07-05
K021229 MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244 Beckman Coulter, Inc. DDR Class II 2002-06-28
K021609 RDI HS CRP KIT Reference Diagnostics, Inc. DCK Class II 2002-06-27
K021081 HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER The Binding Site, Ltd. DFZ Class II 2002-06-17
K020603 CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010 Good Biotech Corp. DCN Class II 2002-06-13
K013213 HYPERION VISIQUANT ANA TEST KIT Hyperion, Inc. DHN Class II 2002-06-04
K021257 ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) Diagnostic Products Corp. LKJ Class II 2002-06-03
K021208 IMMULITE 2000 MIXED ALLERGEN PANELS Diagnostic Products Corp. DHB Class II 2002-05-30
K021206 IMMULITE 2000 SPECIFIC ALLERGENS Diagnostic Products Corp. DHB Class II 2002-05-30
K021192 QACA IGG/IGM ELISA KIT HRP Cheshire Diagnostics , Ltd. MID Class II 2002-05-16
K013787 NYCOCARD CRP Primus Corp. DCK Class II 2002-05-14
K020823 PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT Sanquin Blood Supply Foundation DFZ Class II 2002-05-14
K020566 FUJIREBIO DIAGNOSTICS CA 19-9 RIA Fujirebio Diagnostics,Inc. NIG Class II 2002-05-09
K020757 VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796 Pharmacia Deutschland GmbH MID Class II 2002-05-02
K020348 ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS Axis-Shield Diagnostics, Ltd. JZO Class II 2002-05-02
K020687 DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300 Axis-Shield Diagnostics, Ltd. JZO Class II 2002-05-02
K020752 VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596 Pharmacia Deutschland GmbH MID Class II 2002-05-02
K020758 VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696 Pharmacia Deutschland GmbH MID Class II 2002-05-02
K020349 ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS Axis-Shield Diagnostics, Ltd. JZO Class II 2002-05-02
K020414 QUANTA LITE CCP ELISA Inova Diagnostics, Inc. NHX Class II 2002-04-29
K021103 MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM Zeus Scientific, Inc. LKJ Class II 2002-04-24
K020694 QAB2A IGM ELISA KIT Cheshire Diagnostics , Ltd. MVS Class II 2002-04-19
K020695 QAB2A IGG ELISA KIT Cheshire Diagnostics , Ltd. MSV Class II 2002-04-19
K020387 MYALLERGYTEST SYSTEM Immunetech Corporation DHB Class II 2002-04-17
K011068 RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L Rhigene, Inc. KTL Class II 2002-04-11
K013984 IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR Diagnostic Products Corp. MOI Class II 2002-03-28
K020806 ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY Bayer Corp. LOJ Class II 2002-03-27
K020241 QACA IGG/IGM ELISA KIT Cheshire Diagnostics , Ltd. MID Class II 2002-03-13
K013359 LP(A)-LATEX SEIKEN ASSAY KIT Denka Seiken'S DFC Class II 2002-03-08
K020156 DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T Axis-Shield Diagnostics, Ltd. MID Class II 2002-03-06
K012357 CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM Bayer Diagnostics Corp. MOI Class II 2002-02-28
K013919 TORFLEX TRANSSEPTAL GUIDING SHEATH Baylis Medical Co., Inc. DBY Class I 2002-02-22
K014293 K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET Kamiya Biomedical Co. DBF Class II 2002-02-19
K013785 UROVYSION BLADDER CANCER RECURRENCE KIT Vysis MMW Class II 2002-02-08
K012576 CIC-C1Q EIA American Laboratory Products Co., Ltd. DAK Class II 2002-01-29
K013128 N LATEX LP(A) Dade Behring, Inc. DFC Class II 2002-01-18
K011855 WAMPOLE HS-CRP ELISA Carter-Wallace, Inc. DCN Class II 2002-01-08
K013956 DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN Diamedix Corp. MSV Class II 2002-01-08
K014084 NYCOCARD CRP CONTROL Primus Corp. DCK Class II 2002-01-07
K013304 BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER Becton Dickinson Infusion Therapy Systems, Inc. DBY Class I 2002-01-02
K013628 DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM Diamedix Corp. MSV Class II 2001-12-21
K013568 CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM Bayer Corp. DHX Class II 2001-12-21
K012040 RAMP MYOGLOBIN ASSAY Response Biomedical Corp. DDR Class II 2001-12-18
K013282 GORE INTRODUCER SHEATH W. L. Gore & Associates, Inc. DBY Class I 2001-12-14
K013866 CONVOY ADVANCED DELIVERY SHEATH KIT Boston Scientific DBY Class I 2001-12-14
K011244 ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM Zeus Scientific, Inc. LKJ Class II 2001-12-10
K012337 BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM Bayer Corp. DCN Class II 2001-12-06
K011958 CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT Denka Seiken'S DCN Class II 2001-12-04
K013432 IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G Immuno Concepts, Inc. KTL Class II 2001-11-29
K012361 TINA-QUANT COMPLEMENT C3C TEST SYSTEM Roche Diagnostics Corp. CZW Class II 2001-11-29
K012359 TINA-QUANT COMPLEMENT C4 TEST SYSTEM Roche Diagnostics Corp. DBI Class II 2001-11-29
K013249 TINA-QUANT APOLIPOPROTEIN VER.2 Roche Diagnostics Corp. DER Class II 2001-11-16
K013206 TINA-QUANT APOLIPOPROTEIN B VER.2 Roche Diagnostics Corp. DFC Class II 2001-11-16
K013278 TINA-QUANT APOLIPOPROTEIN A-1 VER.2 Roche Diagnostics Corp. DEL Class I 2001-11-15
K013285 RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15 Immuno Concepts, Inc. MOB Class II 2001-11-14
K013283 RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16 Immuno Concepts, Inc. MOB Class II 2001-11-14
K013207 TINA-QUANT APOLIPOPROTEIN B VER.2 Roche Diagnostics Corp. DFC Class II 2001-11-13
K012449 DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM Diamedix Corp. MID Class II 2001-10-26
K012450 DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM Diamedix Corp. MID Class II 2001-10-26
K012777 ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS Bayer Corp. JZO Class II 2001-10-22
K013135 IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS) Diagnostic Products Corp. DHB Class II 2001-10-19

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