Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Immuno Concepts, Inc. — Predicate Candidate Screening
36 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
75 daysmedian FDA review time
181 days90th percentile
36clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K013432 | IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G | Immuno Concepts, Inc. | 2001-11-29 | 45 | 0 |
| K013285 | RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDAS | Immuno Concepts, Inc. | 2001-11-14 | 43 | 0 |
| K013283 | RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, | Immuno Concepts, Inc. | 2001-11-14 | 43 | 0 |
| K992041 | RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11 | Immuno Concepts, Inc. | 1999-07-23 | 36 | 0 |
| K983924 | HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO | Immuno Concepts, Inc. | 1998-12-18 | 44 | 0 |
| K972145 | HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM | Immuno Concepts, Inc. | 1998-02-24 | 263 | 0 |
| K974463 | IMMUNO CONCEPTS ANCA TEST SYSTEM | Immuno Concepts, Inc. | 1998-02-09 | 75 | 0 |
| K974478 | IMMUNO CONCEPTS ANCA TEST SYSTEMS | Immuno Concepts, Inc. | 1998-02-09 | 75 | 0 |
| K963275 | RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM | Immuno Concepts, Inc. | 1996-09-13 | 24 | 0 |
| K955604 | RELISA SM/RNP ANTIBODY TEST SYSTEM | Immuno Concepts, Inc. | 1996-04-19 | 133 | 0 |
| K955602 | RELSIA SCL-70 ANTIBODY TEST SYSTEM | Immuno Concepts, Inc. | 1996-04-19 | 133 | 0 |
| K955603 | RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM | Immuno Concepts, Inc. | 1996-04-19 | 133 | 0 |
| K955605 | RELISA JO-1 ANTIBODY TEST SYSTEM | Immuno Concepts, Inc. | 1996-04-19 | 133 | 0 |
| K950979 | HEP-2000 COLORZYME ANA-RO TEST SYSTEM | Immuno Concepts, Inc. | 1995-06-01 | 90 | 0 |
| K944096 | HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM | Immuno Concepts, Inc. | 1994-11-21 | 91 | 0 |
| K935129 | RELISA ENA ANTIBODY SCREENING TEST SYSTEM | Immuno Concepts, Inc. | 1994-01-31 | 95 | 1 |
| K932225 | ANTI-CARDIOLIPIN ANTIBODY SCREENING TEST SYSTEM | Immuno Concepts, Inc. | 1993-07-06 | 60 | 0 |
| K911661 | ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM | Immuno Concepts, Inc. | 1991-12-09 | 241 | 0 |
| K912489 | COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS | Immuno Concepts, Inc. | 1991-07-24 | 50 | 0 |
| K912488 | FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS | Immuno Concepts, Inc. | 1991-07-24 | 50 | 0 |
| K895708 | EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI) | Immuno Concepts, Inc. | 1989-12-11 | 77 | 0 |
| K895707 | EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY) | Immuno Concepts, Inc. | 1989-12-08 | 74 | 0 |
| K893465 | CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST) | Immuno Concepts, Inc. | 1989-07-25 | 83 | 0 |
| K893468 | CMV IGG ANTIBODY TEST (INDIRECT FLUORESCENT TEST) | Immuno Concepts, Inc. | 1989-07-14 | 72 | 0 |
| K893467 | CMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST) | Immuno Concepts, Inc. | 1989-07-14 | 72 | 0 |
| K893466 | CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST) | Immuno Concepts, Inc. | 1989-07-14 | 72 | 0 |
| K880884 | EBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME) | Immuno Concepts, Inc. | 1988-08-30 | 181 | 0 |
| K880885 | EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME) | Immuno Concepts, Inc. | 1988-08-30 | 181 | 0 |
| K880883 | EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT) | Immuno Concepts, Inc. | 1988-08-30 | 181 | 0 |
| K880886 | EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT) | Immuno Concepts, Inc. | 1988-08-30 | 181 | 0 |
| K860428 | SM-RNP AUTOANTIBODY TEST SYSTEM | Immuno Concepts, Inc. | 1986-05-15 | 100 | 0 |
| K860644 | SS-A/SS-B AUTOANTIBODY TEST SYSTEM | Immuno Concepts, Inc. | 1986-03-28 | 36 | 0 |
| K843225 | COLORZYME NDNA TEST SYSTEM | Immuno Concepts, Inc. | 1984-11-01 | 77 | 0 |
| K833148 | ENZYME ANA TEST SYSTEM | Immuno Concepts, Inc. | 1983-11-21 | 67 | 1 |
| K810301 | CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST | Immuno Concepts, Inc. | 1981-02-25 | 21 | 0 |
| K803276 | ANA-IFA TEST SYSTEM | Immuno Concepts, Inc. | 1981-01-26 | 28 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda