Immuchem Corp.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Immuchem Corp.” (first 1979, latest 1988), across 15 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 |
|---|---|---|---|
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 2 | 2 |
| JLS | Radioimmunoassay, Progesterone | 2 | 2 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
| CFP | Radioimmunoassay, Immunoreactive Insulin | 1 | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | 1 |
| CHP | Radioimmunoassay, Estradiol | 1 | 1 |
Plus 5 more product codes.
Review panels
Most recent Immuchem Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K883726 | THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL | JLW | 1988-12-15 | 106 |
| K871317 | FOLLICLE STIMULATING HORMONE (HFSH) | CGJ | 1987-05-20 | 48 |
| K871542 | HPROLACTIN KIT | CFT | 1987-05-14 | 24 |
| K865071 | THYROID STIMULATING HORMONE (TSH IRMA) RIA KIT | JLW | 1987-03-13 | 74 |
| K864144 | LUTEINIZING HORMONE (LH-IRMA) RIA KIT | CEP | 1986-11-24 | 33 |
| K860559 | ANDROSTENEDIONE 125I KIT BY RIA | CIZ | 1986-03-14 | 28 |
| K854094 | IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS | JLS | 1986-02-28 | 144 |
| K830962 | IMMUCHEM COVALENT-COAT RIA KIT | DPO | 1983-05-04 | 37 |
| K822509 | COVALENT COAT RIA KIT | CFP | 1982-09-28 | 39 |
| K822140 | IMMUCHEM COVALENT-COAT | JKC | 1982-08-05 | 16 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Immuchem 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Immuchem Corp.?
FDA lists 18 510(k) clearances under the applicant name “Immuchem Corp.” (first 1979, latest 1988), across 15 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 Immuchem Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Immuchem Corp. is 37 days.
Which FDA product codes appear under Immuchem Corp.?
The most frequent FDA product codes under this applicant name are CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone, 2); JLS (Radioimmunoassay, Progesterone, 2); JLW (Radioimmunoassay, Thyroid-Stimulating Hormone, 2).
Next steps
- See all 18 Immuchem Corp. clearances with predicates and recalls
- Run predicate analysis for product code CDZ, Immuchem 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.