Icn Biomedicals, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Icn Biomedicals, Inc.” (first 1988, latest 2003), across 10 product codes in 3 review panels. Median 510(k) review time under this name: 99 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 |
|---|---|---|---|
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 | 2 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | 1 |
| DJR | Enzyme Immunoassay, Methadone | 1 | 1 |
| DKX | Thin Layer Chromatography, Barbiturate | 1 | 1 |
| JCF | Lymphocyte Separation Medium | 1 | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 | 1 |
| JLX | Radioimmunoassay, 17-Hydroxyprogesterone | 1 | 1 |
| JNB | Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine | 1 | 1 |
Review panels
- Clinical Chemistry (8)
- Clinical Toxicology (2)
- Hematology (1)
Most recent Icn Biomedicals, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K030211 | RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016 | DKX | 2003-06-13 | 143 |
| K023252 | RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020 | DJR | 2002-11-22 | 53 |
| K926106 | IMMUCHEM PHE-MW EA | JNB | 1995-02-08 | 797 |
| K922944 | IMMUCHEM LH-MW ELISA | CEP | 1993-02-02 | 229 |
| K922715 | IMMUCHEM PRL-MW ELISA | CFT | 1992-10-05 | 122 |
| K922376 | ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT | CGJ | 1992-10-05 | 138 |
| K920442 | IMMUCHEM TSH-MW ELISA | JLW | 1992-03-18 | 44 |
| K913963 | IMMUCHEM NEONATAL TSH-MP ELISA | JLW | 1991-12-13 | 99 |
| K902445 | LYMPHO SEP(TM) | JCF | 1990-08-22 | 82 |
| K885198 | 17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA | JLX | 1989-02-23 | 69 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Icn Biomedicals, 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 Icn Biomedicals, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Icn Biomedicals, Inc.” (first 1988, latest 2003), across 10 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 Icn Biomedicals, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Icn Biomedicals, Inc. is 99 days.
Which FDA product codes appear under Icn Biomedicals, Inc.?
The most frequent FDA product codes under this applicant name are JLW (Radioimmunoassay, Thyroid-Stimulating Hormone, 2); CEP (Radioimmunoassay, Luteinizing Hormone, 1); CFT (Radioimmunoassay, Prolactin (Lactogen), 1).
Next steps
- See all 11 Icn Biomedicals, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JLW, Icn Biomedicals, 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.