Immuno Concepts, Inc.: FDA filings under this applicant name
FDA lists 36 510(k) clearances under the applicant name “Immuno Concepts, Inc.” (first 1981, latest 2001), across 12 product codes in 2 review panels. Median 510(k) review time under this name: 75 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 8 | 8 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 7 | 7 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 4 | 4 |
| GNP | Antiserum, Cf, Epstein-Barr Virus | 2 | 2 |
| LIN | Antisera, Conjugated Fluorescent, Cytomegalovirus | 2 | 2 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 | 2 |
| LJN | Antibody Igm, If, Epstein-Barr Virus | 2 | 2 |
| LKQ | Antibody Igm,If, Cytomegalovirus Virus | 2 | 2 |
| LLM | Test, Antigen, Nuclear, Epstein-Barr Virus | 2 | 2 |
| LSE | Epstein-Barr Virus, Other | 2 | 2 |
Plus 2 more product codes.
Review panels
- Immunology (24)
- Microbiology (12)
Most recent Immuno Concepts, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K013432 | IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G | KTL | 2001-11-29 | 45 |
| K013285 | RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15 | MOB | 2001-11-14 | 43 |
| K013283 | RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16 | MOB | 2001-11-14 | 43 |
| K992041 | RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11 | LJM | 1999-07-23 | 36 |
| K983924 | HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO | DHN | 1998-12-18 | 44 |
| K972145 | HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM | DHN | 1998-02-24 | 263 |
| K974478 | IMMUNO CONCEPTS ANCA TEST SYSTEMS | MOB | 1998-02-09 | 75 |
| K974463 | IMMUNO CONCEPTS ANCA TEST SYSTEM | MOB | 1998-02-09 | 75 |
| K963275 | RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM | LLL | 1996-09-13 | 24 |
| K955605 | RELISA JO-1 ANTIBODY TEST SYSTEM | LLL | 1996-04-19 | 133 |
26 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2008-12-04.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Immuno Nuclear Corp. (30 510(k)s)
- Immuno Assay Corp. (10 510(k)s)
- Immuno Concepts, N.A. , Ltd. (4 510(k)s)
- Immuno Diagnostic Center, Inc. (3 510(k)s)
- Immuno Pathology Labs (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Immuno Concepts, Inc.?
FDA lists 36 510(k) clearances under the applicant name “Immuno Concepts, Inc.” (first 1981, latest 2001), across 12 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Immuno Concepts, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Immuno Concepts, Inc. is 75 days.
Which FDA product codes appear under Immuno Concepts, Inc.?
The most frequent FDA product codes under this applicant name are LLL (Extractable Antinuclear Antibody, Antigen And Control, 8); DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, 7); MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca), 4).
Next steps
- See all 36 Immuno Concepts, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLL, Immuno Concepts, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.