Immco Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 55 510(k) clearances under the applicant name “Immco Diagnostics, Inc.” (first 1988, latest 2018), across 20 product codes in 3 review panels. Median 510(k) review time under this name: 186 days. Since 2017 the median was 263 days, against 258 days for all cleared 510(k)s in the same product codes. 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 | 1 | 380 |
| 2013 | 1 | 325 |
| 2014 | 0 | — |
| 2015 | 2 | 226 |
| 2016 | 1 | 275 |
| 2017 | 3 | 259 |
| 2018 | 2 | 264 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Immco Diagnostics, Inc. took a median 263 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 258 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 8 | 8 |
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 6 | 6 |
| DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 5 | 5 |
| MID | System, Test, Anticardiolipin Immunological | 5 | 5 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 4 | 4 |
| MST | Antibodies, Gliadin | 4 | 4 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 3 | 3 |
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 3 | 3 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | 2 |
| DHR | System, Test, Rheumatoid Factor | 2 | 2 |
Plus 10 more product codes.
Review panels
- Immunology (53)
- Clinical Chemistry (1)
- Microbiology (1)
Most recent Immco Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K172745 | ImmuGlo HEp-2 Elite IFA | DHN | 2018-06-05 | 266 |
| K172078 | ImmuLisa Enhanced RNA POL III Antibody ELISA | NYO | 2018-03-30 | 263 |
| K163133 | ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA | DBM | 2017-08-08 | 273 |
| K163177 | ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA | MST | 2017-07-28 | 256 |
| K162788 | ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA | MSV | 2017-06-19 | 259 |
| K151559 | ImmuLisa Enhanced Centromere Antibody ELISA | LJM | 2016-03-11 | 275 |
| K143736 | ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA | DHR | 2015-09-23 | 267 |
| K142781 | ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA | LLL | 2015-03-31 | 186 |
| K123713 | IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA | MVM | 2013-10-25 | 325 |
| K113020 | IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS | MID | 2012-10-25 | 380 |
45 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Immco Diagnostics, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Immco Diagnostics, Inc.?
FDA lists 55 510(k) clearances under the applicant name “Immco Diagnostics, Inc.” (first 1988, latest 2018), across 20 product codes in 3 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 Immco Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Immco Diagnostics, Inc. is 186 days. Since 2017: 263 days, versus 258 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Immco Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are LLL (Extractable Antinuclear Antibody, Antigen And Control, 8); MVM (Autoantibodies, Endomysial(Tissue Transglutaminase), 6); DBL (Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control, 5).
Next steps
- See all 55 Immco Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLL, Immco Diagnostics, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.