Immuno-Diagnostic Products, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Immuno-Diagnostic Products, Inc.” (first 1980, latest 1986), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 58 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 |
|---|---|---|---|
| DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 | 1 |
| GLZ | Antigens, If, Toxoplasma Gondii | 1 | 1 |
| GNP | Antiserum, Cf, Epstein-Barr Virus | 1 | 1 |
| GQH | Antigen, Cf (Including Cf Control), Cytomegalovirus | 1 | 1 |
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | 1 | 1 |
| JWL | Antigen, Treponema Pallidum For Fta-Abs Test | 1 | 1 |
Review panels
- Microbiology (5)
- Immunology (3)
Most recent Immuno-Diagnostic Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K854207 | EBV(EPSTEIN-BARR VIRUS) TEST KIT | GNP | 1986-04-24 | 190 |
| K811021 | HERPES | GQN | 1981-11-05 | 204 |
| K811562 | TOXOPLASMOSIS TEST KIT | GLZ | 1981-07-16 | 43 |
| K811022 | ANA TEST KIT | DHN | 1981-04-23 | 8 |
| K801963 | CMV TEST KIT | GQH | 1980-10-23 | 65 |
| K801959 | FTA-ABS TEST | JWL | 1980-10-23 | 65 |
| K801961 | RF-II TEST KIT | DHR | 1980-10-10 | 52 |
| K801960 | ANTI-DS/N-DNA TEST KIT | DBL | 1980-10-10 | 52 |
Recalls
openFDA lists no recalls under a recalling firm named Immuno-Diagnostic Products, 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.
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-Diagnostic Laboratories (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Immuno-Diagnostic Products, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Immuno-Diagnostic Products, Inc.” (first 1980, latest 1986), across 8 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-Diagnostic Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Immuno-Diagnostic Products, Inc. is 58 days.
Which FDA product codes appear under Immuno-Diagnostic Products, Inc.?
The most frequent FDA product codes under this applicant name are DBL (Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control, 1); DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, 1); DHR (System, Test, Rheumatoid Factor, 1).
Next steps
- See all 8 Immuno-Diagnostic Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DBL, Immuno-Diagnostic Products, 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.