meddevicedb.com FDA Device Reference

Review Panel

Immunology FDA 510(k) Clearances & Devices

Cleared Devices
3,548
Product Codes (page)
39
Latest Decision
1994-10-13

Clearances · page 20 of 36

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K933588 APHLELISA KIT Louisville Apl Diagnostics, Inc. MID Class II 1994-10-13
K944375 N/T RHEUMATOLOGY CONTROL SL/1, SL/2 Behring Diagnostics, Inc. DCK Class II 1994-10-03
K944288 HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD) Hemagen Diagnostics, Inc. DCK Class II 1994-10-03
K943997 BEHRING NEPHELOMETER II Behring Diagnostics, Inc. DEW Class II 1994-10-03
K942272 IGM RHEUMATOID FACTOR Immco Diagnostics, Inc. DHR Class II 1994-09-26
K913360 ANTI-RETICULIN ANTIBODY (ARA) TEST Immco Diagnostics, Inc. DBL Class II 1994-09-26
K940403 ELIAS CARDIOLIPIN ANTIBODIES Elias U.S.A., Inc. MID Class II 1994-09-20
K941346 PLASMINOGEN RID TEST KIT The Binding Site, Ltd. DDX Class I 1994-09-09
K940243 VENTANA EMA PRIMARY ANDIBODY Ventana Medical Systems, Inc. DHF Class I 1994-09-07
K943205 HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION) Research Diagnostics, Inc. DAS Class I 1994-09-07
K943098 HUMAN IGG SUBCLASSES ELISA COMBI KIT Research Diagnostics, Inc. DAS Class I 1994-09-07
K940362 ANA SCREEN ELISA TEST SYSTEM Zeus Scientific, Inc. LLL Class II 1994-07-28
K936010 THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY Biomerica, Inc. DDC Class II 1994-07-18
K941840 HEMAGEN ACL IGA CALIBRATOR Hemagen Diagnostics, Inc. MID Class II 1994-06-30
K941509 RADIAS ANA SCREEN ENZYME IMMUNOASSAY Bio-Rad LJM Class II 1994-06-30
K935847 AXSYM FERRITIN Abbott Laboratories DBF Class II 1994-06-21
K924726 DAKO MOUSE ANTI-HUMAN B-CELL (DAKO-C020-L26 MONO ANTI Dako Corp. DEH Class II 1994-06-13
K932136 DAKO MOUSE ANTI-HUMAN MELANOMA (DAKO ANTI-HMB45) Dako Corp. DEH Class II 1994-06-13
K941409 ENA PROFILE-6 ELISA TEST SYSTEM Zeus Scientific, Inc. LJM Class II 1994-06-10
K941014 ENA SCREEN ELISA TEST SYSTEM Zeus Scientific, Inc. LJM Class II 1994-06-10
K940585 SELISA ANTI-N DNA ANTIBODIES Cambridge Life Sciences Plc. LRM Class II 1994-06-10
K940700 AUTOZYME SCREEN Cambridge Life Sciences Plc. LJM Class II 1994-06-10
K935413 ENA EIA TEST KIT David A. Fuccillo, Ph.D. LLL Class II 1994-06-02
K940422 IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER The Binding Site, Ltd. DFZ Class II 1994-05-27
K940183 HY-TEC TOTAL IGE ENZYME IMMUNOASSAY Hycor Biomedical, Inc. DGC Class II 1994-05-17
K940622 ELIAS ENA SCREEN (MICROTITER PLATE) Elias U.S.A., Inc. LLL Class II 1994-05-11
K940229 SYN ENA SCREEN (PIN PLATE) Elias U.S.A., Inc. LLL Class II 1994-05-11
K941358 THYROGLOBULIN EIA TEST KIT Immunoprobe, Inc. JNL Class II 1994-05-11
K941361 MICROSOMAL EIA TEST KIT Immunoprobe, Inc. JNL Class II 1994-05-11
K935417 JO-1 EIA TEST KIT David A. Fuccillo, Ph.D. LLL Class II 1994-05-05
K935418 SCL-70 EIA TEST KIT David A. Fuccillo, Ph.D. LLL Class II 1994-05-05
K935419 LA EIA TEST KIT David A. Fuccillo, Ph.D. LLL Class II 1994-05-05
K940251 MITOCHONDRIA EIA TEST KIT David A. Fuccillo, Ph.D. DBM Class II 1994-05-03
K935415 RNP EIA TEST KIT David A. Fuccillo, Ph.D. LJM Class II 1994-05-02
K935414 SM EIA TEST KIT David A. Fuccillo, Ph.D. LJM Class II 1994-05-02
K940253 HISTONE EIA TEST KIT David A. Fuccillo, Ph.D. LJM Class II 1994-05-02
K935416 RO EIA TEST KIT David A. Fuccillo, Ph.D. LJM Class II 1994-05-02
K940353 BECKMAN BETA-2-MICROGLOBULIN (B2M) Beckman Instruments, Inc. JZG Class II 1994-04-21
K934594 MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM Ciba Corning Diagnostics Corp. DGC Class II 1994-04-21
K934324 OT IGG SORBENT Organon Teknika Corp. DEW Class II 1994-04-21
K935828 HEMAGEN ENA SCREEN-6 KIT (EIA METHOD) Hemagen Diagnostics, Inc. LLL Class II 1994-04-20
K940510 ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT Helix Diagnostics, Inc. LKP Class II 1994-04-20
K940588 ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT Helix Diagnostics, Inc. LKO Class II 1994-04-20
K931979 VENTANA NEGATIVE CONTROL REAGENT Ventana Medical Systems, Inc. DEM Class II 1994-03-30
K935468 SYNELISA ANA TOTAL Elias U.S.A., Inc. LJM Class II 1994-03-25
K940641 ELIAS ANA TOTAL Elias U.S.A., Inc. LJM Class II 1994-03-25
K933970 N-ASSAY TIA IGM Crestat Diagnostics, Inc. CFN Class II 1994-03-22
K935488 ALATOP(R) MICROPLATE ALLERGY SCREEN Diagnostic Products Corp. DHB Class II 1994-03-22
K933972 N-ASSAY TIA IGG Crestat Diagnostics, Inc. CFF Class II 1994-03-22
K933971 N-ASSAY TIA IGA Crestat Diagnostics, Inc. CFN Class II 1994-03-22
K935876 ACCESS SPECIFIC IGE ASSAY Bio-Rad Laboratories, Inc. DHB Class II 1994-03-11
K934524 MAST CLA ALLERGY SYSTEM Mast Immunosystems DHB Class II 1994-03-07
K926420 MAST CLA ALLERGY SYSTEM Mast Immunosystems DHB Class II 1994-03-07
K935129 RELISA ENA ANTIBODY SCREENING TEST SYSTEM Immuno Concepts, Inc. LLL Class II 1994-01-31
K933973 N-ASSAY TIA MULTI V-NL Crestat Diagnostics, Inc. CFN Class II 1994-01-28
K935528 DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH E.I. Dupont DE Nemours & Co., Inc. DBF Class II 1994-01-28
K933712 EL-RF TEST SYSTEM: EL-RF-IGM KIT Theratest Laboratories, Inc. DHR Class II 1994-01-28
K935288 SYNELISA CARDIOLIPIN ANTIBODIES Elias U.S.A., Inc. MID Class II 1994-01-24
K930796 ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERS Alko Diagnostic Corp. JZX Class I 1994-01-13
K934966 SPQ PAL CONTROL LEVEL II Incstar Corp. DDS Class I 1994-01-11
K933078 BECKMAN ALPHA-1-MICROGLOBULIN (A1M) REAGENT Beckman Instruments, Inc. MGA Class I 1994-01-11
K935075 SPQ CRP CONTROL LEVEL II Incstar Corp. DCN Class II 1994-01-11
K930778 IMMUNOCARD MONO Meridian Diagnostics, Inc. KTN Class II 1993-12-27
K934053 QUANTA LITE(TM) HISTONE ELISA Inova Diagnostics, Inc. LLL Class II 1993-12-21
K933267 AUTOANTIBODY PROFILE-6 ELISA TEST SYSTEM Zeus Scientific, Inc. LJM Class II 1993-12-15
K933392 ELIAS CARDIOLIPIN IGM ANTIBODIES Elias U.S.A., Inc. MID Class II 1993-12-08
K933393 ELIAS CARDIOLIPIN IGG ANTIBODIES Elias U.S.A., Inc. MID Class II 1993-12-08
K932206 SYNELISA ANA PROFILE Elias U.S.A., Inc. LJM Class II 1993-12-03
K934473 LACTOFERRIN MICROASSAY SYSTEM Touch Scientific, Inc. DEG Class I 1993-12-03
K932876 DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT Shield Diagnostics, Ltd. LKJ Class II 1993-11-15
K933589 BOEHRINGER MANNHEIM TINA-QUANT TRANSFERRIN ASSAY Boehringer Mannheim Corp. DDG Class II 1993-11-03
K932877 DIASTAT ANTI-CENTROMERE KIT Shield Diagnostics, Ltd. LLL Class II 1993-10-15
K926272 BECKMAN TRANSFERRIN KIT Beckman Instruments, Inc. DDG Class II 1993-10-07
K933648 ADDED USE CLAIM FOR DUPONT ACA BETA-2-MICROGLOBULIN TEST PACK Dupont Medical Products JZG Class II 1993-09-24
K931255 SYNELISA CENP-B ANTIBODIES Elias U.S.A., Inc. LKJ Class II 1993-09-24
K932850 ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN Helix Diagnostics, Inc. LLL Class II 1993-09-24
K931702 IMMULITE BETA-2-MICROGLOBULIN Diagnostic Products Corp. JZG Class II 1993-09-24
K931543 ENCORE ENA COMBINED EIA Clark Laboratories, Inc. LLL Class II 1993-09-08
K932688 EYE SPOT IM TEST J.S. Medical Assoc. KTN Class II 1993-09-08
K933314 RADIAS FERRITIN ENZYME IMMUNOASSAY Bio-Rad DEW Class II 1993-09-08
K932302 SYLNELISA HISTONE ANTIBODIES Elias U.S.A., Inc. LKJ Class II 1993-08-23
K932180 EYE SPOT CRP TEST J.S. Medical Assoc. DCN Class II 1993-08-23
K933123 SYNELISA TG ANTIBODIES/TPO ANTIBODIES Elias U.S.A., Inc. JZS Class I 1993-08-23
K932437 EYE SPOT RF TEST J & S Medical Assoc., Inc. DHR Class II 1993-08-23
K932679 RHEUMELISA II HISTONE ANTIBODY TEST KIT Biowhittaker Molecular Applications, Inc. LKJ Class II 1993-08-23
K931703 IMMULITE TOTAL IGE Diagnostic Products Corp. JHR Class II 1993-08-16
K932424 ANA PROFILE I Apotex Scientific, Inc. LJM Class II 1993-08-10
K930987 CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE) The Binding Site, Ltd. KTL Class II 1993-08-10
K932386 VENTANA RED DETECTION KIT Ventana Medical Systems, Inc. DEY Class II 1993-08-09
K932551 ACCUTEX IM LATEX TEST J.S. Medical Assoc. KTN Class II 1993-08-09
K932326 PSA ANTIBODY KIT Ventana Medical Systems, Inc. DEH Class II 1993-08-06
K933180 QUANTA LITE MITOCHONDRIA M2 ELISA Inova Diagnostics, Inc. DGC Class II 1993-08-05
K931576 VISTA FERRITIN ASSAY Syva Co. DBF Class II 1993-08-05
K932419 ANTI-SS-B/LA ANTIBODY TEST Helix Diagnostics, Inc. LLL Class II 1993-08-05
K930890 COBAS(R) CORE IGE TOTAL EIA Roche Diagnostic Systems, Inc. DGC Class II 1993-08-05
K930422 SYNELISA PARIETAL CELL ANTIBODIES Elias U.S.A., Inc. DBJ Class II 1993-08-03
K931806 IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE The Binding Site, Ltd. CZP Class II 1993-07-16
K931495 ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT Helix Diagnostics, Inc. LLL Class II 1993-07-16
K932373 HEMAGEN CARDIOLIPIN ANTIBODY KIT (EIA METHOD0 Hemagen Diagnostics, Inc. MID Class II 1993-07-16
K931901 LACTOCARD Touch Scientific, Inc. DEG Class I 1993-07-06

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