meddevicedb.com FDA Device Reference

Review Panel

Immunology FDA 510(k) Clearances & Devices

Cleared Devices
3,548
Product Codes (page)
39
Latest Decision
1999-11-23

Clearances · page 13 of 36

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K993273 N LATEX FERRITIN Dade Behring, Inc. DBF Class II 1999-11-23
K993669 LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET DiaSorin, Inc. DFC Class II 1999-11-17
K993086 AUTOSTAT II ANTI-GLIADIN IGA ELISA Cogent Diagnotics , Ltd. MST Class II 1999-11-12
K992790 BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG Brahms Diagnostica, LLC JZO Class II 1999-11-12
K993109 VARELISA RECOMBI ANA PROFILE Pharmacia & Upjohn Co. LJM Class II 1999-11-12
K993108 VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96 Pharmacia & Upjohn Co. LJM Class II 1999-11-12
K993087 AUTOSTAT II ANTI-GLIADIN IGG ELISA Cogent Diagnotics , Ltd. MST Class II 1999-11-12
K993162 WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR Wako Chemicals USA, Inc. DDG Class II 1999-11-12
K993250 THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM. Zeus Scientific, Inc. MST Class II 1999-11-12
K992791 BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO Brahms Diagnostica, LLC JZO Class II 1999-11-12
K993281 K-ASSAY IGG Kamiya Biomedical Co. DEW Class II 1999-11-09
K991907 ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM Bayer Corp. CZW Class II 1999-11-09
K993034 MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD Medica, Inc. MVM Class II 1999-11-01
K992976 K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR Kamiya Biomedical Co. DDR Class II 1999-11-01
K993354 K-ASSAY APO B Kamiya Biomedical Co. DER Class II 1999-10-28
K993294 DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM Diamedix Corp. LKJ Class II 1999-10-25
K993345 K-ASSAY APO AI Kamiya Biomedical Co. DER Class II 1999-10-25
K991385 DADE BEHRING N HIGH SENSITIVITY CRP ASSAY Dade Behring, Inc. DCK Class II 1999-10-25
K992878 ANTI-TISSUE TRANSGLUTAMINASE (TTG)ANTIBODY TEST Immco Diagnostics, Inc. MVM Class II 1999-10-15
K992517 BIOCHECK FERRITIN ELISA MODEL BC-1025 Biocheck, Inc. DBF Class II 1999-09-24
K992528 BIOCHECK IGE ELISA, MODEL BC-1035 Biocheck, Inc. DGC Class II 1999-09-21
K992440 AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA Cogent Diagnotics , Ltd. MID Class II 1999-09-21
K992488 TOTAL HAEMOLYTIC COMPLEMENT RID KIT The Binding Site, Ltd. DAE Class II 1999-09-17
K992312 K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B Kamiya Biomedical Co. DCK Class II 1999-09-13
K992311 K-ASSAY CRP(1), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATORC Kamiya Biomedical Co. DCK Class II 1999-09-13
K992224 VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT Hemagen Diagnostics, Inc. MSV Class II 1999-08-30
K992243 VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT Hemagen Diagnostics, Inc. MSV Class II 1999-08-30
K992241 VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT Hemagen Diagnostics, Inc. MSV Class II 1999-08-30
K991942 AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA Cogent Diagnotics , Ltd. MLE Class II 1999-08-24
K991720 KRONUS OPTIQUANT THYROGLOBULIN KIT Unchanged MSW Class II 1999-08-09
K991890 AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA Cogent Diagnotics , Ltd. MVJ Class II 1999-08-09
K991316 TOUCH TEAR IGE MICROASSAY KIT Touch Scientific, Inc. DGC Class II 1999-08-09
K992157 CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY Chiron Diagnostics Corp. DBF Class II 1999-08-05
K991157 N LATEX STFR REAGENT Dade Behring, Inc. DDG Class II 1999-08-02
K991945 PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 Pharmacia & Upjohn Co. DGC Class II 1999-07-28
K992041 RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11 Immuno Concepts, Inc. LJM Class II 1999-07-23
K990234 QUALISYS PSA IMMUNOASSAY Qualisys Diagnostics, Inc. LTJ Class II 1999-07-08
K991787 N LATEX IGE MONO REAGENT Dade Behring, Inc. DGC Class II 1999-07-07
K990998 POLYSLIT IFE KIT Helena Laboratories CFF Class II 1999-06-28
K991610 ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM. Zeus Scientific, Inc. DDC Class II 1999-06-25
K990138 DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 Diagnostic Systems Laboratories, Inc. LOJ Class II 1999-06-21
K991179 ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM Zeus Scientific, Inc. DDC Class II 1999-06-17
K991657 QUANTA LITE ANA ELISA Inova Diagnostics, Inc. LLL Class II 1999-06-17
K991467 K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET Kamiya Biomedical Co. DHR Class II 1999-06-10
K991409 K-ASSAY RHEUMATOID FACTOR Kamiya Biomedical Co. DHR Class II 1999-06-09
K991796 IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5 Diagnostic Products Corp. DDR Class II 1999-06-09
K990431 AIA-PACK CA 125 Tosoh Medics, Inc. LTK Class II 1999-06-03
K991372 CRP Abbott Laboratories DCN Class II 1999-06-01
K991707 MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206 Beckman DHX Class II 1999-06-01
K990943 VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK Ortho-Clinical Diagnostics, Inc. DHX Class II 1999-06-01
K983875 VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II REAGENT PACK Ortho-Clinical Diagnostics, Inc. LTK Class II 1999-05-14
K991048 ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216, F235, F237, F242, F255, F259, F2 Pharmacia & Upjohn Co. DHB Class II 1999-05-14
K991224 K-ASSAY CRP Kamiya Biomedical Co. DCK Class II 1999-05-14
K983715 THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) Bayer Corp. LTK Class II 1999-05-14
K991094 IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6 Diagnostic Products Corp. JZO Class II 1999-05-13
K991096 IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06 Diagnostic Products Corp. JZO Class II 1999-05-13
K991210 K-ASSAY CRP CALIBRATOR SET Kamiya Biomedical Co. DCK Class II 1999-05-11
K990774 ABBOTT ARCHITECT CEA Abbott Laboratories DHX Class II 1999-05-11
K991136 B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM Olympus America, Inc. JZG Class II 1999-05-11
K990704 ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT Beckman Coulter, Inc. DCK Class II 1999-05-03
K990796 AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA Cogent Diagnotics , Ltd. MOB Class II 1999-04-28
K990798 AUTOSTAT II ANTI-JO-1 ELISA Cogent Diagnotics , Ltd. LLL Class II 1999-04-28
K990624 AUTOSTAT II ANTI-SM/RNP ELISA Cogent Diagnotics , Ltd. LKO Class II 1999-04-28
K990797 AUTOSTAT II ANTI-SCL-70 ELISA Cogent Diagnotics , Ltd. LLL Class II 1999-04-28
K990626 AUTOSTAT II ANTI-SS-B/LA ELISA Cogent Diagnotics , Ltd. LLL Class II 1999-04-28
K990625 AUTOSTAT II ANTI-SM ELISA Cogent Diagnotics , Ltd. LKP Class II 1999-04-28
K990627 AUTOSTAT II ANTI-SS-A/RO ELISA Cogent Diagnotics , Ltd. LLL Class II 1999-04-28
K991277 MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5 Diagnostic Products Corp. DDR Class II 1999-04-27
K990915 INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY Stellar Bio Systems, Inc. DHN Class II 1999-04-21
K990916 INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY Stellar Bio Systems, Inc. KTL Class II 1999-04-21
K990825 REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE Dade Behring, Inc. DCN Class II 1999-04-16
K990594 INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 Roche Diagnostics Corp. DER Class II 1999-04-14
K990595 INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B Roche Diagnostics Corp. DFC Class II 1999-04-14
K990587 ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01 Bio-Rad DHR Class II 1999-04-07
K990886 IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5 Diagnostic Products Corp. DCK Class II 1999-04-06
K982708 SPQ TEST SYSTEM DiaSorin, Inc. DFC Class II 1999-04-02
K990204 GLIADIN IGG ELISA TEST SYSTEM Zeus Scientific, Inc. MST Class II 1999-03-26
K990207 GLIADIN IGA ELISA TEST SYSTEM Zeus Scientific, Inc. MST Class II 1999-03-26
K990551 IGG FLEX REAGENT CARTRIDGE Dade Behring, Inc. CFQ Class II 1999-03-25
K990552 IMMUNOGLOBULIN A TEST SYSTEM Dade Behring, Inc. CFQ Class II 1999-03-25
K990553 IGM FLEX REAGENT CARTRIDGE Dade Behring, Inc. CFQ Class II 1999-03-22
K984102 ACL/APS FACS KIT Louisville Apl Diagnostics, Inc. MID Class II 1999-03-18
K982466 IMMULITE THYROGLOBULIN MODEL LKTY Diagnostic Products Corp. MSW Class II 1999-03-12
K984289 VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK Ortho-Clinical Diagnostics, Inc. LTJ Class II 1999-03-12
K982468 IMMULITE 2000 THYROGLOBULIN MODEL L2KTY Diagnostic Products Corp. MSW Class II 1999-03-12
K981446 WAKO AUTOKIT LP(A) Wako Chemicals USA, Inc. DFC Class II 1999-03-09
K990035 RF Abbott Laboratories DHR Class II 1999-03-08
K984619 BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT The Binding Site, Ltd. MVJ Class II 1999-02-23
K973910 GLIADIN ANTIBODIES ELISA Genesis Diagnostics , Ltd. MST Class II 1999-02-17
K984336 QUANTA LITE GBM ELISA Inova Diagnostics, Inc. MVJ Class II 1999-02-08
K984326 ELECYS IGE ASSAY Boehringer Mannheim Corp. JHR Class II 1999-02-08
K983695 ANTICARDIOLIPIN IGGAM SCREEN EIA DIAGNOSTIC TEST KIT The Binding Site, Ltd. MID Class II 1999-02-05
K983696 ANTICARDIOLIPIN IGA SCREEN EIA DIAGNOSTIC TEST KIT The Binding Site, Ltd. MID Class II 1999-02-05
K983692 ANTICARDIOLIPIN IGG SCREEN EIA DIAGNOSTIC TEST The Binding Site, Ltd. MID Class II 1999-02-05
K983694 ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT The Binding Site, Ltd. MID Class II 1999-02-05
K984163 ANTI-TPO EIA DIAGNOSTIC TEST KIT The Binding Site, Ltd. JZO Class II 1999-02-02
K984228 IS ANTI-TPO IGG ELISA TEST SYSTEM Columbia Bioscience, Inc. JZO Class II 1999-02-02
K984186 NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY Nichols Institute Diagnostics DBF Class II 1999-02-02
K984165 ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT The Binding Site, Ltd. JZO Class II 1999-02-02
K983690 VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK Ortho-Clinical Diagnostics, Inc. MOI Class II 1999-02-02

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