Immuno Assay Corp.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Immuno Assay Corp.” (first 1981, latest 1984), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 18 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 |
|---|---|---|---|
| CDX | Radioimmunoassay, Total Thyroxine | 2 | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| CEF | Electrophoretic, Protein Fractionation | 1 | 1 |
| CGR | Radioimmunoassay, Cortisol | 1 | 1 |
| DNL | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep. | 1 | 1 |
| DPO | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep. | 1 | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
| JQG | Radiometric, Fe59, Iron Binding Capacity | 1 | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 | 1 |
Review panels
Most recent Immuno Assay Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K833842 | RIA COAT DIGOXIN | DPO | 1984-01-17 | 75 |
| K833745 | RIACOAT T-4 | CDX | 1984-01-04 | 70 |
| K820089 | TSH (RIA) KIT | JLW | 1982-01-28 | 15 |
| K820074 | CORTISOL (RIA) KIT | CGR | 1982-01-28 | 16 |
| K811954 | COMBO-FER IRON DIAGNOSTIC | JQG | 1981-07-27 | 19 |
| K811725 | TBG DIAGNOSTIC KIT | CEF | 1981-07-10 | 22 |
| K811213 | T3 (RIA) KIT | CDP | 1981-05-29 | 25 |
| K811212 | DIGOXIN (RIA) KIT | DNL | 1981-05-21 | 17 |
| K810857 | T3 UPTAKE KIT | KHQ | 1981-04-08 | 9 |
| K810811 | T4 RIA KIT | CDX | 1981-04-07 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Immuno Assay 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 Nuclear Corp. (30 510(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 Assay Corp.?
FDA lists 10 510(k) clearances under the applicant name “Immuno Assay Corp.” (first 1981, latest 1984), across 9 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 Assay Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Immuno Assay Corp. is 18 days.
Which FDA product codes appear under Immuno Assay Corp.?
The most frequent FDA product codes under this applicant name are CDX (Radioimmunoassay, Total Thyroxine, 2); CDP (Radioimmunoassay, Total Triiodothyronine, 1); CEF (Electrophoretic, Protein Fractionation, 1).
Next steps
- See all 10 Immuno Assay Corp. clearances with predicates and recalls
- Run predicate analysis for product code CDX, Immuno Assay 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, 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.