meddevicedb.com FDA Device Reference

Review Panel

Immunology FDA 510(k) Clearances & Devices

Cleared Devices
3,548
Product Codes (page)
39
Latest Decision
1998-09-03

Clearances · page 15 of 36

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K981929 BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT The Binding Site, Ltd. MST Class II 1998-09-03
K982366 QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) ELISA Inova Diagnostics, Inc. MVM Class II 1998-08-27
K982087 ROCHE CRP T CONTROL N Roche Diagnostic Systems, Inc. DCK Class II 1998-08-18
K982150 EL-ANA PROFILES: EL-ENA/4 Theratest Laboratories, Inc. LLL Class II 1998-08-13
K982622 EL-ANA PROFILES: EL-ENA/5 Theratest Laboratories, Inc. LLL Class II 1998-08-13
K981839 ACS:CENTAUR PSA2 IMMUNOASSAY Chiron Diagnostics Corp. LTJ Class II 1998-08-12
K981478 ACS:CENTAUR CEA Chiron Diagnostics Corp. DHX Class II 1998-08-12
K973243 ACTIVE PSA ELISA (DSL-10-9700) Diagnostic Systems Laboratories, Inc. LTJ Class II 1998-08-03
K973244 ACTIVE PSA IRMA (DSL-9700) Diagnostic Systems Laboratories, Inc. LTJ Class II 1998-08-03
K981857 QUANTA LITE TPO ELISA Inova Diagnostics, Inc. LLL Class II 1998-07-29
K974111 QUIDEL CH50 EQ EIA Quidel Corp. DAE Class II 1998-07-29
K981750 WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM Wieslab AB MOB Class II 1998-07-22
K981748 WIELISA ANCA SCREENING KIT TEST SYSTEM Wieslab AB MOB Class II 1998-07-22
K981030 BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT The Binding Site, Ltd. MOB Class II 1998-07-20
K981029 BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT The Binding Site, Ltd. MOB Class II 1998-07-20
K981698 ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) Chiron Corp. MOI Class II 1998-07-10
K981592 ACS:CENTAUR AFP Chiron Diagnostics Corp. LOQ Class II 1998-07-07
K981559 UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY Pharmacia & Upjohn Co. JZO Class II 1998-07-07
K981930 UNICAP THYROID PEROXIDASE IGG Pharmacia & Upjohn Co. JZO Class II 1998-07-07
K981536 QUANTECH MYOGLOBIN ASSAY Hellen Professional Services MVE Class II 1998-06-29
K980887 ELECSYS CEA ON THE ELECSYS 1010 Boehringer Mannheim Corp. DHX Class II 1998-06-29
K981328 QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT Inova Diagnostics, Inc. MOB Class II 1998-06-19
K981330 QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT Inova Diagnostics, Inc. MOB Class II 1998-06-19
K980540 SERAQUEST ANTI-SM Quest Intl., Inc. LKP Class II 1998-06-15
K980639 SERAQUEST ANTI-SSB Quest Intl., Inc. LLL Class II 1998-06-15
K981496 COLOR-SLIDE RF Seradyn, Inc. DHR Class II 1998-06-15
K981638 IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT Beckman Coulter, Inc. DCK Class II 1998-06-12
K981237 QUANTA LITE RIBOSOME P ELISA Inova Diagnostics, Inc. MQA Class II 1998-06-05
K981014 ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM Zeus Scientific, Inc. MID Class II 1998-06-02
K981021 ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM Zeus Scientific, Inc. MID Class II 1998-06-02
K981012 AIA-PACK MYOGLOBIN ASSAY Tosoh Medics, Inc. DDR Class II 1998-05-28
K981020 ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM Zeus Scientific, Inc. MID Class II 1998-05-18
K980810 SERAQUEST ANTI-SSA Quest Intl., Inc. LJM Class II 1998-05-12
K980337 DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM Helix Diagnostics, Inc. LJM Class II 1998-05-12
K980811 SERAQUEST ANTI-SM/RNP Quest Intl., Inc. LKP Class II 1998-05-12
K981354 ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 Beckman Instruments, Inc. LOJ Class II 1998-05-01
K981282 ELECSYS AFP Roche Diagnostics GmbH LOJ Class II 1998-05-01
K980206 IMMULITE ANTI-TG AB Diagnostic Products Corp. JZO Class II 1998-05-01
K981102 STRATUS CS MYOGLOBIN (MYO) TESTPAK Dade Behring, Inc. DDR Class II 1998-04-27
K980391 SERAQUEST ANTI-DSDNA Quest Intl., Inc. LRM Class II 1998-04-24
K980759 DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM Diamedix Corp. LLL Class II 1998-04-23
K980376 THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM Bayer Corp. LTJ Class II 1998-04-23
K974842 IMMULITE 2000 3RD GENERATION PSA Diagnostic Products Corp. LTJ Class II 1998-04-21
K980855 IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT Dpc Cirrus DHX Class II 1998-04-21
K971402 BARD BTA TRAK TEST Bard Diagnostic Sciences,Inc. MMW Class II 1998-04-15
K980716 ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY Nichols Institute Diagnostics LTJ Class II 1998-04-03
K980312 NOVA LITE ENDOMYSIAL Inova Diagnostics, Inc. DBL Class II 1998-04-02
K980240 ELECSYS CA 125II ON THE ELECSYS 1010 Boehringer Mannheim Corp. LTK Class II 1998-03-25
K980230 QUANTA LITE B2 GPI SCREEN Inova Diagnostics, Inc. MSV Class II 1998-03-24
K972162 ELECSYS CA 125 II Boehringer Mannheim Corp. LTK Class II 1998-03-18
K972873 IMMUSTRIP HAMA IGG Immunomedics, Inc. DAK Class II 1998-03-17
K980190 ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM) Chiron Corp. MOI Class II 1998-03-06
K974889 DIAMEDIX IS-RF TEST SYSTEM Diamedix Corp. DHR Class II 1998-03-06
K972591 HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT Morax JKM Class II 1998-03-04
K974694 IS-DSDNA TEST SYSTEM Diamedix Corp. LRM Class II 1998-03-03
K972145 HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM Immuno Concepts, Inc. DHN Class II 1998-02-24
K974816 ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229 Beckman Instruments, Inc. LTJ Class II 1998-02-20
K974429 RAPET CRP Stanbio Laboratory DCN Class II 1998-02-18
K974505 AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501 Alfa Biotech (Uk) , Ltd. DBF Class II 1998-02-17
K974701 ORGENTEC ANTI-MPO (P-ANCA) ELISA American Laboratory Products Co., Ltd. MOB Class II 1998-02-17
K974166 WIELISA MPO ANCA TEST SYSTEM Wieslab AB MOB Class II 1998-02-17
K974564 IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT Beckman Instruments, Inc. DEB Class II 1998-02-17
K974167 WIELISA PR-3 ANCA TEST SYSTEM Wieslab AB MOB Class II 1998-02-17
K974702 ORGENTEC ANTI-PR3 (C-ANCA) ELISA American Laboratory Products Co., Ltd. MOB Class II 1998-02-17
K974370 RAPET RF Stanbio Laboratory DHR Class II 1998-02-17
K974169 WIELISA ANTI-GBM TEST SYSTEM Wieslab AB DBL Class II 1998-02-17
K974580 ALLERGEN IMMUNOCAP F256,F245,F207,F202 Pharmacia & Upjohn Co. DHB Class II 1998-02-09
K974463 IMMUNO CONCEPTS ANCA TEST SYSTEM Immuno Concepts, Inc. MOB Class II 1998-02-09
K974350 ALLERGAN IMMUNO CAP M4, M8, K70 Pharmacia, Inc. DHB Class II 1998-02-09
K973692 UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE United Biotech, Inc. DCK Class II 1998-02-09
K974478 IMMUNO CONCEPTS ANCA TEST SYSTEMS Immuno Concepts, Inc. MOB Class II 1998-02-09
K972639 TINA-QUANT HAPTOGLOBIN Boehringer Mannheim Corp. DAD Class II 1998-01-09
K972638 TINA-QUANT PREALBUMIN Boehringer Mannheim Corp. JZJ Class I 1998-01-09
K972640 TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY Boehringer Mannheim Corp. DEM Class II 1998-01-09
K974189 ELECSYS PSA (ON ELECSYS 1010) Boehringer Mannheim Corp. LTJ Class II 1998-01-06
K973040 SPIFE IFE-6 Helena Laboratories CFF Class II 1998-01-02
K971905 DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING Dako Corp. DEH Class II 1997-12-12
K974325 CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN Chiron Diagnostics Corp. DDR Class II 1997-12-08
K972790 THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCR Theratest Laboratories, Inc. MSV Class II 1997-12-05
K973882 EL-B2GP1SCR Theratest Laboratories, Inc. MSV Class II 1997-12-05
K964703 THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) Bayer Corp. MOI Class II 1997-12-01
K972457 MONOCOL/LEX-IM TEST Immunostics Inc., KTN Class II 1997-12-01
K972456 RHEUMACOL RHEUMATOID FACTOR TEST Immunostics Inc., DHR Class II 1997-11-25
K974050 SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT Beckman Instruments, Inc. DCK Class II 1997-11-24
K973351 ELECSYS AFP Boehringer Mannheim Corp. LOJ Class II 1997-11-21
K973813 IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT Beckman Instruments, Inc. JZG Class II 1997-11-20
K973823 PR 3 ANTIBODY KIT Hemagen Diagnostics, Inc. MOB Class II 1997-11-13
K973822 VIRGO ANCA SCREEN KIT Hemagen Diagnostics, Inc. MOB Class II 1997-11-13
K973824 VIRGO PANCO KIT Hemagen Diagnostics, Inc. MOB Class II 1997-11-13
K964407 IMX CA 15-3 Abbott Laboratories MOI Class II 1997-11-10
K970302 APO-TEK LP(A) Perimmune, Inc. DFC Class II 1997-11-10
K965022 MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751) Dako Corp. DEH Class II 1997-11-06
K964185 IMX CA 125 Abbott Diagnostics LTK Class II 1997-11-04
K964020 AXSYM CA 125 Abbott Laboratories LTK Class II 1997-11-04
K964098 CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM Bayer Corp. LTK Class II 1997-10-31
K972021 IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5) Diagnostic Products Corp. LTJ Class II 1997-10-31
K965141 TRUQUANT BR RIA Biomira USA, Inc. MOI Class II 1997-10-31
K971689 IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT Euro-Diagnostica AB MOB Class II 1997-10-29
K971464 IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT Euro-Diagnostica AB DBL Class II 1997-10-29
K973196 ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS Zeus Scientific, Inc. MID Class II 1997-10-29

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