meddevicedb.com FDA Device Reference

Review Panel

Immunology FDA 510(k) Clearances & Devices

Cleared Devices
3,548
Product Codes (page)
31
Latest Decision
1996-05-23

Clearances · page 18 of 36

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K950169 RIBOSOMAL P EIA TEST SYSTEM Hogan & Hartson MQA Class II 1996-05-23
K954830 ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY Orgentec LKP Class II 1996-05-08
K954831 ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY Orgentec LKO Class II 1996-05-08
K961277 RF IGM ELISA TEST SYSTEM Zeus Scientific, Inc. DHR Class II 1996-05-08
K955431 RIT LIVER, KIDNEY, STOMACH IFA KIT The Binding Site, Ltd. DBL Class II 1996-04-23
K960703 RF-LATEX SEIKEN REAGENT SYSTEM Globe Management Support, Inc. DHR Class II 1996-04-19
K955602 RELSIA SCL-70 ANTIBODY TEST SYSTEM Immuno Concepts, Inc. LLL Class II 1996-04-19
K955604 RELISA SM/RNP ANTIBODY TEST SYSTEM Immuno Concepts, Inc. LLL Class II 1996-04-19
K955605 RELISA JO-1 ANTIBODY TEST SYSTEM Immuno Concepts, Inc. LLL Class II 1996-04-19
K955603 RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM Immuno Concepts, Inc. LLL Class II 1996-04-19
K960702 CRP-LATEX SEIKEN XR REAGENT SYSTEM Globe Management Support, Inc. DCK Class II 1996-04-19
K954832 ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY Orgentec LJM Class II 1996-04-18
K954829 ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY Orgentec LJM Class II 1996-04-18
K954815 ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY Orgentec LJM Class II 1996-04-18
K954814 ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY Orgentec LJM Class II 1996-04-18
K953495 EIA KIT FOR THE DETECTION OF GBM ANTIBODIES Scimedx Corp. DBL Class II 1996-04-10
K955797 IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR Randox Laboratories, Ltd. DFT Class II 1996-04-05
K955794 IGA IMMUNOTURBIDIMETRIC & CALIBRATOR Randox Laboratories, Ltd. CZP Class II 1996-04-05
K955798 IGG IMMUNOTURBIDIMETRIC & CALIBRATOR Randox Laboratories, Ltd. DEW Class II 1996-04-05
K954896 HYTEC AUTOIMMUNE KITS (SM) Hycor Biomedical, Inc. LKP Class II 1996-03-22
K935161 KERATIN PRIMARY ANTIBODY Ventana Medical Systems, Inc. DEH Class II 1996-03-22
K955881 RETINOL BINDING RID KIT The Binding Site, Ltd. CZS Class I 1996-03-22
K941173 ANTI-KERATIN-HMW PRIMARY ANTI-BODY Ventana Medical Systems, Inc. DEH Class II 1996-03-22
K954897 HYTEC AUTOIMMUNE KITS (RNP) Hycor Biomedical, Inc. LKO Class II 1996-03-22
K954895 HYTEC AUTOIMMUNE KIT (JO-1) Hycor Biomedical, Inc. LLL Class II 1996-03-20
K955134 ORGENTEC ENASCREEN ELISA ASSAY Orgentec LLL Class II 1996-03-20
K955133 ORGENTEC ENASCREEN PIN IMMUNO ASSAY Orgentec LLL Class II 1996-03-20
K954893 HYTEC AUTOMIMMUNE KIT (DS-DNA) Hycor Biomedical, Inc. LRM Class II 1996-03-20
K954894 HYTEC AUTOIMMUNE KITS (SCL-70) Hycor Biomedical, Inc. LLL Class II 1996-03-20
K960091 ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT Helix Diagnostics, Inc. LRM Class II 1996-03-20
K960182 DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM Mardx Diagnostics, Inc. LRM Class II 1996-03-20
K955022 QUANTA LITE MPO Inova Diagnostics, Inc. MOB Class II 1996-03-19
K954062 EIA KIT FOR THE DETECTION OF ANTI-MPO ANTIBODIES Scimedx Corp. MOB Class II 1996-03-19
K955021 QUANTA LITE PR3 Inova Diagnostics, Inc. MOB Class II 1996-03-19
K954105 EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES Scimedx Corp. MOB Class II 1996-03-19
K960324 HEMAGEN CRP 150 KIT (EIA METHOD) Hemagen Diagnostics, Inc. DCK Class II 1996-03-12
K955481 THERATEST KIT (MODIFICATION) Theratest Laboratories, Inc. LJM Class II 1996-03-06
K954380 QUANTA LITE SSDNA Inova Diagnostics, Inc. LJM Class II 1996-02-29
K936111 CHEMMATE SPECIAL STAIN LCA-CD45 Biotek Solutions, Inc. DEH Class II 1996-02-27
K940331 KERATIN PRIMARY ANTIBODY Ventana Medical Systems, Inc. DEH Class II 1996-02-26
K955857 N PROTEIN STANDARS SY Behring Diagnostics, Inc. CZW Class II 1996-02-21
K955156 WAKO AUTOKIT CRP NEW Wako Chemicals USA, Inc. DCK Class II 1996-02-16
K960067 IMMILITE TOTAL IGE Diagnostic Products Corp. JHR Class II 1996-02-14
K954537 OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT Olympus America, Inc. DCN Class II 1996-02-14
K952523 CARDIOLIPIN IGG EIA TEST KIT Immunoprobe, Inc. MID Class II 1996-02-09
K955907 BOEHRINGER MANNHEIM IGA ASSAY Boehringer Mannheim Corp. CZP Class II 1996-02-09
K952521 CARDIOLIPIN IGM EIA TEST SYSTEM Immunoprobe, Inc. MID Class II 1996-02-09
K952522 CARDIOLIPIN IGA EIA TEST SYSTEM Immunoprobe, Inc. MID Class II 1996-02-09
K955908 BOEHRINGER MANNHEIM IGM ASSAY Boehringer Mannheim Corp. DAO Class II 1996-02-09
K955906 BOEHRINGER MANNHEIM IGG ASSAY Boehringer Mannheim Corp. DFZ Class II 1996-02-09
K946068 HUMAN BETA-2 MICROGLOBULIN ENHANCED RADIAL IMMUNODIFFUSION KIT The Binding Site, Ltd. JZG Class II 1996-01-30
K946069 HUMAN BETA-2 MICROGLOBULIN ENHANCED NEPHELOMETRIC KIT The Binding Site, Ltd. JZG Class II 1996-01-30
K941993 PHARMACIA CAP SYSTEM PHADIATOP FEIA Pharmacia, Inc. DHB Class II 1996-01-30
K946070 HUMAN BETA-2 MICROGLOBULIN TURBINDIMETRIC KIT The Binding Site, Ltd. JZG Class II 1996-01-30
K953586 VARELISA PR3-ANCA Elias U.S.A., Inc. MOB Class II 1996-01-26
K953587 VARELISA MPO-ANCA Elias U.S.A., Inc. MOB Class II 1996-01-26
K946217 CARDIOLIPIN M EIA TEST SYSTEM Hogan & Hartson MID Class II 1996-01-24
K946215 CARDIOLIPIN G EIA TEST SYSTEM Hogan & Hartson MID Class II 1996-01-24
K946216 CARDIOLIPIN A EIA TEST SYSTEM Hogan & Hartson MID Class II 1996-01-24
K954890 HYTEC AUTOMMUNE KIT (ENA) Hycor Biomedical, Inc. LLL Class II 1995-12-26
K954891 HYTEC AUTOIMMUNE KITS (SS-B) Hycor Biomedical, Inc. LKJ Class II 1995-12-26
K954892 HYTEC AUTOMIMMUNE KIT (RF) Hycor Biomedical, Inc. DHR Class II 1995-12-26
K954392 HYTEC AUTOIMMUNE KIT (SS-A) Hycor Biomedical, Inc. LKJ Class II 1995-12-26
K954657 WAKO AUTOKIT APO B Wako Chemicals USA, Inc. DFC Class II 1995-12-20
K955086 TEST, RHEUMATOID FACTOR Polymedco, Inc. DHR Class II 1995-12-20
K954447 C-REACTIVE PROTEIN LATEX KIT Randox Laboratories, Ltd. DCK Class II 1995-12-18
K954145 WAKO AUTOKIT CH50 Wako Chemicals USA, Inc. DAE Class II 1995-12-18
K952287 REAADS ANTI-PHOSPHATIDYLSERINE QUANTITATIVE TEST KIT Reaads Medical Products, Inc. MID Class II 1995-12-18
K954566 SPECIFIC ALLERGEN MODULES FOR THE ALASTAT MICROPLATE ALLERGEN-SPECIFIC IGE SYSTEM Diagnostic Products Corp. DHB Class II 1995-12-18
K952490 IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUM Roche Image Analysis Systems LJM Class II 1995-12-15
K954700 ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT Helix Diagnostics, Inc. LKJ Class II 1995-12-15
K954723 ENZYME IMMUNOASSAY ANA SCREENING TEST KIT Helix Diagnostics, Inc. LKJ Class II 1995-12-15
K955042 CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM Shared Systems, Inc. DCN Class II 1995-12-13
K950149 CHEMMATE(TM) LAMBDA Biotek Solutions, Inc. DEH Class II 1995-12-06
K954256 ANTI-TPO Biomerica, Inc. JNL Class II 1995-11-27
K951364 MICROSOMAL EIA TEST KIT Immunoprobe, Inc. JNL Class II 1995-11-20
K951362 THYROGLOBULIN EIA TEST KIT Immunoprobe, Inc. JNL Class II 1995-11-20
K954106 THERATEST LAB, INC., EL-ANASCR KIT Theratest Laboratories, Inc. LJM Class II 1995-11-14
K953780 ACCESS ALLERGEN DOG EPITHELIM Bio-Rad Laboratories, Inc. DHB Class II 1995-11-14
K953671 ORGEN TEC ANTI-DSDNA ELISA ASSAY Orgentec LRM Class II 1995-11-09
K940424 VENTANA BLUE DETECTION KIT Ventana Medical Systems, Inc. DEH Class II 1995-11-06
K950150 CHEMMATE(TM) KAPPA Biotek Solutions, Inc. DFH Class II 1995-10-27
K950152 CHEMMATE(TM) UCHL1 (CD45-RO) Biotek Solutions, Inc. DFH Class II 1995-10-27
K951363 CARDIOLIPIN IGG,M,A EIA TEST SYSTEM Immunoprobe, Inc. MID Class II 1995-10-13
K951639 COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE) Incstar Corp. DAE Class II 1995-10-13
K950151 CHEMMATE(TM) L26 (CD20) Biotek Solutions, Inc. DEH Class II 1995-10-04
K951187 VARELISA CARDIOLIPIN ABS SCREEN Elias U.S.A., Inc. MID Class II 1995-10-02
K950728 QUICKVUE ONE-STEP ALLERGEN SCREEN Quidel Corp. DHB Class II 1995-10-02
K951634 ACCESS MYOGLOBIN REAGENTS Bio-Rad Laboratories, Inc. DDR Class II 1995-09-27
K950716 THERATEST EL-ANA PROFILES TEST SYSTEM Theratest Laboratories, Inc. LJM Class II 1995-09-26
K953926 LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM International Enzymes, Inc. DCK Class II 1995-09-15
K952520 CARDIOLIPIN IGG,M,A EIA TEST KIT Immunoprobe, Inc. MID Class II 1995-09-15
K953927 LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM International Enzymes, Inc. DCF Class II 1995-09-15
K953366 QUANTA LITE IGA ACA (HRP) Inova Diagnostics, Inc. MID Class II 1995-09-01
K953291 QUANTA LITE ACA SCREEN (HRP) Inova Diagnostics, Inc. MID Class II 1995-08-29
K951320 AURAFLEX TG-AB AND TPO-AB Organon Teknika Corp. JNL Class II 1995-08-25
K952607 AURAFLEX TPO-AB Organon Teknika Corp. JNL Class II 1995-08-25
K942326 HUMAN C5 RID KITS Jay H. Geller DAY Class II 1995-08-24
K953520 OLYMPUS RHEUMATOID FACTOR IMMUNOTURBIDIMETRIC REAGENT Olympus America, Inc. DHR Class II 1995-08-24
K952253 ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT Helix Diagnostics, Inc. LLL Class II 1995-08-24

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