Medical Device Manufacturer · US , Mchenry , IL

Immuno Concepts, Inc.

36 submissions · 36 cleared · Since 1981
36
Total
36
Cleared
0
Denied

Immuno Concepts, Inc. — FDA 510(k) Submissions

Immuno Concepts, Inc. has submitted 36 FDA 510(k) premarket notifications since 1981, of which 36 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Extractable Antinuclear Antibody, Antigen And Control, Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, Test System, Antineutrophil Cytoplasmic Antibodies (anca), Antiserum, Cf, Epstein-barr Virus, Antibody Igm, If, Epstein-barr Virus . Use the specialty filter in the sidebar to narrow results.

36 devices
1–25 of 36
IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G
K013432 · KTL Anti-dna Indirect... · Immunology
Nov 2001 45d
RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16
K013283 · MOB Test System,... · Immunology
Nov 2001 43d
RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15
K013285 · MOB Test System,... · Immunology
Nov 2001 43d
RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11
K992041 · LJM Antinuclear Antibody... · Immunology
Jul 1999 36d
HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO
K983924 · DHN Antinuclear Antibody,... · Immunology
Dec 1998 44d
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
K972145 · DHN Antinuclear Antibody,... · Immunology
Feb 1998 263d
IMMUNO CONCEPTS ANCA TEST SYSTEM
K974463 · MOB Test System,... · Immunology
Feb 1998 75d
IMMUNO CONCEPTS ANCA TEST SYSTEMS
K974478 · MOB Test System,... · Immunology
Feb 1998 75d
RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM
K963275 · LLL Extractable Antinuclear... · Immunology
Sep 1996 24d
RELSIA SCL-70 ANTIBODY TEST SYSTEM
K955602 · LLL Extractable Antinuclear... · Immunology
Apr 1996 133d
RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM
K955603 · LLL Extractable Antinuclear... · Immunology
Apr 1996 133d
RELISA SM/RNP ANTIBODY TEST SYSTEM
K955604 · LLL Extractable Antinuclear... · Immunology
Apr 1996 133d
RELISA JO-1 ANTIBODY TEST SYSTEM
K955605 · LLL Extractable Antinuclear... · Immunology
Apr 1996 133d
HEP-2000 COLORZYME ANA-RO TEST SYSTEM
K950979 · DHN Antinuclear Antibody,... · Immunology
Jun 1995 90d
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
K944096 · DHN Antinuclear Antibody,... · Microbiology
Nov 1994 91d
RELISA ENA ANTIBODY SCREENING TEST SYSTEM
K935129 · LLL Extractable Antinuclear... · Immunology
Jan 1994 95d
ANTI-CARDIOLIPIN ANTIBODY SCREENING TEST SYSTEM
K932225 · MID System, Test,... · Immunology
Jul 1993 60d
ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM
K911661 · MID System, Test,... · Immunology
Dec 1991 241d
FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS
K912488 · LSE Epstein-barr Virus, Other · Microbiology
Jul 1991 50d
COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS
K912489 · LSE Epstein-barr Virus, Other · Microbiology
Jul 1991 50d
EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI)
K895708 · LLM Test, Antigen, Nuclear,... · Microbiology
Dec 1989 77d
EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY)
K895707 · LLM Test, Antigen, Nuclear,... · Microbiology
Dec 1989 74d
CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST)
K893465 · LKQ Antibody Igm,if,... · Microbiology
Jul 1989 83d
CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST)
K893466 · LKQ Antibody Igm,if,... · Microbiology
Jul 1989 72d
CMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST)
K893467 · LIN Antisera, Conjugated... · Microbiology
Jul 1989 72d
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