Immuno Nuclear Corp.: FDA filings under this applicant name
FDA lists 30 510(k) clearances under the applicant name “Immuno Nuclear Corp.” (first 1981, latest 1986), across 10 product codes in 2 review panels. Median 510(k) review time under this name: 37 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 |
|---|---|---|---|
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 14 | 14 |
| CEW | Radioimmunoassay, Parathyroid Hormone | 4 | 4 |
| CFL | Radioimmunoassay, Human Growth Hormone | 2 | 2 |
| CGC | Radioimmunoassay, Gastrin | 2 | 2 |
| CHO | Radioimmunoassay, Cyclic Amp | 2 | 2 |
| CKG | Radioimmunoassay, Acth | 2 | 2 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | 1 |
| DGC | Ige, Antigen, Antiserum, Control | 1 | 1 |
| JKD | Radioimmunoassay, C-Peptides Of Proinsulin | 1 | 1 |
Review panels
- Clinical Chemistry (15)
- Immunology (15)
Most recent Immuno Nuclear Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K863743 | BIOTECH'S IGE IMMUNO RESPONSE TEST ISOTOPE UNIT | DHB | 1986-12-15 | 82 |
| K863973 | ELM ALLERGEN DISC | DHB | 1986-12-01 | 48 |
| K863844 | IMMUNO BIOTECH'S LAMB'S QUARTERS ALLERGEN DISC | DHB | 1986-10-29 | 28 |
| K863123 | IMMUNO BIOTECH MUGWART ALLERGEN DISC | DHB | 1986-10-01 | 48 |
| K863098 | MEADOW FESCUE ALLERGEN DISC | DHB | 1986-09-15 | 33 |
| K862266 | MAPLE ALLERGEN DISC | DHB | 1986-08-19 | 67 |
| K862939 | ORCHARD GRASS ALLERGEN DISC | DHB | 1986-08-15 | 11 |
| K862938 | JUNE GRASS ALLERGEN DISC | DHB | 1986-08-15 | 11 |
| K862265 | COTTONWOOD ALLERGEN DISC | DHB | 1986-08-15 | 63 |
| K862176 | RUSSIAN THISTLE ALLERGEN DISC | DHB | 1986-08-15 | 67 |
20 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Immuno Nuclear Corp..
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 Concepts, Inc. (36 510(k)s)
- Immuno-Mycologics, Inc. (26 510(k)s)
- Immuno-Products Industries (12 510(k)s)
- Immuno Assay Corp. (10 510(k)s)
- Immuno-Diagnostic Products, Inc. (8 510(k)s)
- Immuno Concepts, N.A. , Ltd. (4 510(k)s)
- Immuno Diagnostic Center, Inc. (3 510(k)s)
- Immuno-Diagnostic Laboratories (2 510(k)s)
- Immuno Pathology Labs (1 510(k)s)
- Immuno-U.S., Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Immuno Nuclear Corp.?
FDA lists 30 510(k) clearances under the applicant name “Immuno Nuclear Corp.” (first 1981, latest 1986), across 10 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 Nuclear Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Immuno Nuclear Corp. is 37 days.
Which FDA product codes appear under Immuno Nuclear Corp.?
The most frequent FDA product codes under this applicant name are DHB (System, Test, Radioallergosorbent (Rast) Immunological, 14); CEW (Radioimmunoassay, Parathyroid Hormone, 4); CFL (Radioimmunoassay, Human Growth Hormone, 2).
Next steps
- See all 30 Immuno Nuclear Corp. clearances with predicates and recalls
- Run predicate analysis for product code DHB, Immuno Nuclear Corp.'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.