meddevicedb.com FDA Device Reference

Review Panel

Immunology FDA 510(k) Clearances & Devices

Cleared Devices
3,548
Product Codes (page)
40
Latest Decision
1997-03-07

Clearances · page 17 of 36

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K962730 HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY Hycor Biomedical, Inc. LRM Class II 1997-03-07
K962728 HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY Hycor Biomedical, Inc. LLL Class II 1997-03-07
K962729 HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY Hycor Biomedical, Inc. DHR Class II 1997-03-07
K962720 HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY Hycor Biomedical, Inc. LLL Class II 1997-03-07
K962719 HYCOR HY.TEC/MANUAL SS-A AUTO-ANTIBODY Hycor Biomedical, Inc. LLL Class II 1997-03-07
K962731 HYCOR HY.TEC/MANUAL JO-1 AUTO-ANTIBODY Hycor Biomedical, Inc. LLL Class II 1997-03-07
K962722 HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODY Hycor Biomedical, Inc. LLL Class II 1997-03-07
K962578 HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY Hycor Biomedical, Inc. LLL Class II 1997-03-07
K964843 IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT Beckman Instruments, Inc. JZH Class II 1997-03-06
K963974 IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN Beckman Instruments, Inc. DEW Class II 1997-03-06
K965108 SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT Beckman Instruments, Inc. DEW Class II 1997-03-06
K964385 ELIAS ANA-HEP-2 Elias U.S.A., Inc. LJM Class II 1997-03-06
K952567 AUTOSTATTMII ANTI-DSDNA Cogent Diagnotics , Ltd. LRM Class II 1997-03-04
K963425 GENZYME DIAGNOSTICS CONTRAST MONO Genzyme Diagnostics KTN Class II 1997-02-25
K970198 IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES Scimedx Corp. DHN Class II 1997-02-20
K941784 VENTANA ANTI-CD8 PRIMARY ANTIBODY Ventana Medical Systems, Inc. DEH Class II 1997-02-14
K941604 VENTANA ANTI-CD4 PRIMARY ANTIBODY Ventana Medical Systems, Inc. DEH Class II 1997-02-14
K941397 ANTI-VIMENTIN PRIMARY ANTIBODY Ventana Medical Systems, Inc. DEH Class II 1997-02-10
K965213 STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY Dade Intl., Inc. DDR Class II 1997-02-10
K941516 VENTANNA ANTI-DESMIN PRIMARY ANTIBODY Ventana Medical Systems, Inc. DEH Class II 1997-02-10
K963868 IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) Beckman Instruments, Inc. DEW Class II 1997-02-10
K964260 IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAG Beckman Instruments, Inc. DFH Class II 1997-02-10
K963139 OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT Olympus America, Inc. DDD Class II 1997-02-06
K963680 TARGET MYOGLOBIN TEST Texas Immunology, Inc. DDR Class II 1997-02-06
K961024 BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB Princeton BioMeditech Corp. KTN Class II 1997-02-04
K963498 FERR FLEX REAGENT CARTRIDGE Dade Chemistry Systems, Inc. JMG Class II 1997-01-24
K954214 CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT Vysis OXP Class II 1997-01-21
K963695 IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ Diagnostic Products Corp. JZO Class II 1997-01-17
K962873 CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE Vysis OVQ Class II 1997-01-13
K964165 MICRO21 WITH NDNA Triangle Biomedical Sciences, Inc. DHN Class II 1997-01-03
K962976 PHARMACIA CAP SYSTEM RAST FEIA Pharmacia & Upjohn Co. DHB Class II 1996-12-23
K940242 VENTANA CEA PRIMARY ANTIBODY Ventana Medical Systems, Inc. DFD Class II 1996-12-23
K962049 C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT Polymedco, Inc. DCK Class II 1996-12-18
K962050 THERATEST EL-RFSCR Theratest Laboratories, Inc. DHR Class II 1996-12-16
K964687 N LATEX CRP MONO REAGENT Behring Diagnostics, Inc. DCH Class II 1996-12-16
K964415 N-ASSAY TIA RHEUMATOID FACTOR TEST KIT Kamiya Technology Services DHR Class II 1996-12-13
K964418 N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET Kamiya Technology Services DHR Class II 1996-12-13
K962276 HEMAGEN ENA DSDNA KIT (EIA METHOD) Hemagen Diagnostics, Inc. DHN Class II 1996-12-05
K963170 OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT Olympus America, Inc. DBF Class II 1996-12-02
K953591 CEP 8 SPECTRUMORANGE DNA PROBE KIT Vysis OYU Class II 1996-11-29
K962450 HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE Hycor Biomedical, Inc. LJM Class II 1996-11-25
K962451 HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO) Hycor Biomedical, Inc. JNL Class II 1996-11-25
K962341 HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG) Hycor Biomedical, Inc. JNL Class II 1996-11-25
K962452 HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA Hycor Biomedical, Inc. DBM Class II 1996-11-25
K962019 C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST Teco Diagnostics DCK Class II 1996-11-25
K962015 RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST Teco Diagnostics DHR Class II 1996-11-25
K962057 ORGENTEC ANTI-RNP/SM ELISA American Laboratory Products Co., Ltd. LJM Class II 1996-11-18
K963245 IMMULITE LATEX-SPECIFIC IGE Diagnostic Products Corp. DHB Class II 1996-11-18
K962062 ORGENTEC ANTI-SM ELISA American Laboratory Products Co., Ltd. LJM Class II 1996-11-18
K962054 ORGENTEC ANTI-SS-A(RO) ELISA American Laboratory Products Co., Ltd. LJM Class II 1996-11-15
K962053 ORGENTEC ANTI-JO-1 ELISA American Laboratory Products Co., Ltd. LJM Class II 1996-11-15
K962052 ORGENTEC ABTI-SS-BB(LA) ELISA American Laboratory Products Co., Ltd. LJM Class II 1996-11-15
K962055 ORGENTEC ANTI-SCL 70 ELISA American Laboratory Products Co., Ltd. LJM Class II 1996-11-15
K963525 DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT Shield Diagnostics, Ltd. DBL Class II 1996-11-07
K963048 IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT Beckman Instruments, Inc. DHR Class II 1996-11-04
K963061 IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT Beckman Instruments, Inc. DCK Class II 1996-11-04
K962409 OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT Olympus America, Inc. CZW Class II 1996-10-18
K962582 OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT Olympus America, Inc. DBI Class II 1996-10-18
K961889 SPECIFIC ALLERGEN MODULES AND MIXED ALLERGEN PANELS FOR ALASTAT MICROPLATE AND ALASTAT EIA ALLERGEN-SPECIFIC IGE SYSTEMS Diagnostic Products Corp. DHB Class II 1996-10-10
K962926 ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY American Laboratory Products Co., Ltd. MID Class II 1996-10-10
K963286 IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT Beckman Instruments, Inc. DAD Class II 1996-10-07
K963427 IMMAGE IMMUNOCHEMISTRY SYSTEM TRANSFERRIN (TRF) REAGENT Beckman Instruments, Inc. DDG Class II 1996-10-07
K955596 N LATEX B2-MICROGLOBULIN REAGENT Behring Diagnostics, Inc. JZG Class II 1996-10-03
K963291 VARELISA ANA (4) PROFILE Elias U.S.A., Inc. LJM Class II 1996-09-30
K962360 IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES Scimedx Corp. MOB Class II 1996-09-30
K961815 QUALITROL ANA CONTROL SERUM SET Consolidated Technologies, Inc. LKJ Class II 1996-09-27
K962198 QUANTEX C4 Instrumentation Laboratory CO DBI Class II 1996-09-26
K962202 QUANTEX IGG Instrumentation Laboratory CO DEW Class II 1996-09-26
K962200 QUANTEX IGA Instrumentation Laboratory CO CZP Class II 1996-09-25
K962201 QUANTEX IGM Instrumentation Laboratory CO DFT Class II 1996-09-25
K962199 QUANTEX C3 Instrumentation Laboratory CO CZW Class II 1996-09-25
K961550 QUALITROL MONO CONTROL SERUM SET Consolidated Technologies, Inc. KTN Class II 1996-09-24
K961545 QUALITROL RF CONTROLS Consolidated Technologies, Inc. DHR Class II 1996-09-24
K961544 QUALITROL IGAME CONTROLS, LEVELS 1 AND 2 Consolidated Technologies, Inc. DGR Class I 1996-09-24
K963275 RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM Immuno Concepts, Inc. LLL Class II 1996-09-13
K962274 UNICAP 100 Pharmacia, Inc. DHB Class II 1996-09-12
K962836 HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD) Hemagen Diagnostics, Inc. DHR Class II 1996-09-12
K941782 VENTANA ANTI-CD5 PRIMARY ANTIBODY Ventana Medical Systems, Inc. DEH Class II 1996-09-10
K962469 ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY American Laboratory Products Co., Ltd. MID Class II 1996-09-09
K962499 ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER Bartels, Inc. JZT Class I 1996-09-05
K961765 MPO ELISA TEST SYSTEM Immunoprobe, Inc. MOB Class II 1996-08-19
K961829 QUALITROL CRP CONTROL SET Consolidated Technologies, Inc. DCK Class II 1996-08-19
K961764 PR-3 ELISA TEST SYSTEM Immunoprobe, Inc. MOB Class II 1996-08-19
K962344 MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) Bayer Corp. DDR Class II 1996-08-15
K960257 N ANTISERUM TO C1 INHIBITOR Behring Diagnostics, Inc. DBA Class II 1996-08-01
K961824 COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN Roche Diagnostic Systems, Inc. DCF Class II 1996-07-23
K960669 HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS Morax CFF Class II 1996-07-12
K962373 N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2 Behring Diagnostics, Inc. DCK Class II 1996-07-11
K961913 QUANTA LITE ENA 6 ELISA Inova Diagnostics, Inc. LLL Class II 1996-07-10
K962523 N LATEX CRP MONO REAGENT Behring Diagnostics, Inc. DCK Class II 1996-07-10
K961340 NOVA LITE ANCA Inova Diagnostics, Inc. MOB Class II 1996-07-10
K951965 DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION Dako Corp. DEH Class II 1996-07-05
K950148 CHEMMATE(TM) CD43 Biotek Solutions, Inc. DEH Class II 1996-07-02
K961169 RHEUMATOID FACTOR LATEX SLIDE TEST KIT Randox Laboratories, Ltd. DHR Class II 1996-06-26
K960370 THYROGLOBULIN ANTIBODY ELISA Immco Diagnostics, Inc. JZO Class II 1996-06-20
K960369 THYROID PEROXIDASE ANTIBODY ELISA Immco Diagnostics, Inc. JZO Class II 1996-06-20
K960987 LIQUICHEK RHEUMATOID FACTOR CONTROL Bio-Rad DHR Class II 1996-06-04
K955303 DIASTAT ANTI-CARDIOLIPIN KIT Shield Diagnostics, Ltd. MID Class II 1996-05-30
K941505 VENTANNA ANTI-CD3 PRIMARY ANTIBODY Ventana Medical Systems, Inc. DEH Class II 1996-05-30
K955449 ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY American Laboratory Products Co., Ltd. MID Class II 1996-05-23

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