Company ยท US
Immuno Concepts, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2001. Name variants (Inc, Corp, punctuation) are merged.
36510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 9 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 8 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 4 |
| GNP | Antiserum, Cf, Epstein-Barr Virus | 2 |
| LIN | Antisera, Conjugated Fluorescent, Cytomegalovirus | 2 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 |
| LJN | Antibody Igm, If, Epstein-Barr Virus | 2 |
| LKQ | Antibody Igm,If, Cytomegalovirus Virus | 2 |
| LLM | Test, Antigen, Nuclear, Epstein-Barr Virus | 2 |
| LSE | Epstein-Barr Virus, Other | 2 |
| MID | System, Test, Anticardiolipin Immunological | 2 |
| KTL | Anti-Dna Indirect Immunofluorescent Solid Phase | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 29, 2001 | K013432 | IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G Immuno Concepts, Inc. | KTL |
| Nov 14, 2001 | K013285 | RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15 Immuno Concepts, Inc. | MOB |
| Nov 14, 2001 | K013283 | RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16 Immuno Concepts, Inc. | MOB |
| Jul 23, 1999 | K992041 | RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11 Immuno Concepts, Inc. | LJM |
| Dec 18, 1998 | K983924 | HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO Immuno Concepts, Inc. | DHN |
| Feb 24, 1998 | K972145 | HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM Immuno Concepts, Inc. | DHN |
| Feb 9, 1998 | K974478 | IMMUNO CONCEPTS ANCA TEST SYSTEMS Immuno Concepts, Inc. | MOB |
| Feb 9, 1998 | K974463 | IMMUNO CONCEPTS ANCA TEST SYSTEM Immuno Concepts, Inc. | MOB |
| Sep 13, 1996 | K963275 | RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM Immuno Concepts, Inc. | LLL |
| Apr 19, 1996 | K955605 | RELISA JO-1 ANTIBODY TEST SYSTEM Immuno Concepts, Inc. | LLL |
| Apr 19, 1996 | K955604 | RELISA SM/RNP ANTIBODY TEST SYSTEM Immuno Concepts, Inc. | LLL |
| Apr 19, 1996 | K955603 | RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM Immuno Concepts, Inc. | LLL |
| Apr 19, 1996 | K955602 | RELSIA SCL-70 ANTIBODY TEST SYSTEM Immuno Concepts, Inc. | LLL |
| Jun 1, 1995 | K950979 | HEP-2000 COLORZYME ANA-RO TEST SYSTEM Immuno Concepts, Inc. | DHN |
| Nov 21, 1994 | K944096 | HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM Immuno Concepts, Inc. | DHN |
| Jan 31, 1994 | K935129 | RELISA ENA ANTIBODY SCREENING TEST SYSTEM Immuno Concepts, Inc. | LLL |
| Jul 6, 1993 | K932225 | ANTI-CARDIOLIPIN ANTIBODY SCREENING TEST SYSTEM Immuno Concepts, Inc. | MID |
| Dec 9, 1991 | K911661 | ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM Immuno Concepts, Inc. | MID |
| Jul 24, 1991 | K912489 | COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS Immuno Concepts, Inc. | LSE |
| Jul 24, 1991 | K912488 | FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS Immuno Concepts, Inc. | LSE |
| Dec 11, 1989 | K895708 | EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI) Immuno Concepts, Inc. | LLM |
| Dec 8, 1989 | K895707 | EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY) Immuno Concepts, Inc. | LLM |
| Jul 25, 1989 | K893465 | CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST) Immuno Concepts, Inc. | LKQ |
| Jul 14, 1989 | K893468 | CMV IGG ANTIBODY TEST (INDIRECT FLUORESCENT TEST) Immuno Concepts, Inc. | LIN |
| Jul 14, 1989 | K893467 | CMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST) Immuno Concepts, Inc. | LIN |
| Jul 14, 1989 | K893466 | CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST) Immuno Concepts, Inc. | LKQ |
| Aug 30, 1988 | K880886 | EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT) Immuno Concepts, Inc. | LJN |
| Aug 30, 1988 | K880885 | EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME) Immuno Concepts, Inc. | GNP |
| Aug 30, 1988 | K880884 | EBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME) Immuno Concepts, Inc. | LJN |
| Aug 30, 1988 | K880883 | EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT) Immuno Concepts, Inc. | GNP |
| May 15, 1986 | K860428 | SM-RNP AUTOANTIBODY TEST SYSTEM Immuno Concepts, Inc. | LLL |
| Mar 28, 1986 | K860644 | SS-A/SS-B AUTOANTIBODY TEST SYSTEM Immuno Concepts, Inc. | LLL |
| Nov 1, 1984 | K843225 | COLORZYME NDNA TEST SYSTEM Immuno Concepts, Inc. | DHN |
| Nov 21, 1983 | K833148 | ENZYME ANA TEST SYSTEM Immuno Concepts, Inc. | LJM |
| Feb 25, 1981 | K810301 | CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST Immuno Concepts, Inc. | DHN |
| Jan 26, 1981 | K803276 | ANA-IFA TEST SYSTEM Immuno Concepts, Inc. | DHN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2009 | Immuno Concepts Inc RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system, manufactured by Immuno Concepts N.A. Ltd., Sacramento, CA. Terminated |
LLL | K935129 |
| Apr 6, 2009 | Immuno Concepts Inc ANA Fluorescent Test System and ANA Colorzyme Test System, Sub assembly catalog number SA 2013, Kit Catalog Numbers, 2000, 2002, 2003, 2004, 2005, 2100, 2200, 4000, 4200, 8024.1, and 8060, manufacture Terminated |
DHN | K803276 K833148 |