Amersham Corp.: FDA filings under this applicant name
FDA lists 94 510(k) clearances under the applicant name “Amersham Corp.” (first 1976, latest 1992), across 41 product codes in 6 review panels. Median 510(k) review time under this name: 40 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under GE HealthCare, based on public ownership records.
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 |
|---|---|---|---|
| CDP | Radioimmunoassay, Total Triiodothyronine | 7 | 7 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 7 | 7 |
| DBF | Ferritin, Antigen, Antiserum, Control | 6 | 6 |
| CEC | Radioimmunoassay, Free Thyroxine | 5 | 5 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 5 | 5 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 4 | 4 |
| CGI | Radioimmunoassay, Estriol | 4 | 4 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 4 | 4 |
| JLS | Radioimmunoassay, Progesterone | 4 | 4 |
| KGI | Densitometer, Bone | 4 | 4 |
Plus 31 more product codes.
Review panels
- Clinical Chemistry (69)
- Radiology (9)
- Immunology (8)
- Clinical Toxicology (4)
- Hematology (1)
- Microbiology (1)
Most recent Amersham Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K914135 | AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086 | CFT | 1992-02-18 | 155 |
| K912733 | AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT | CIG | 1991-07-22 | 32 |
| K912766 | AMERLITE CK-MB ASSAY | JHY | 1991-07-17 | 23 |
| K904666 | AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008 | JLW | 1990-11-02 | 18 |
| K902760 | AMERSHAM TSH CONTROL SERA | JJX | 1990-07-27 | 32 |
| K901857 | GADOLINIUM-153 BONE DENSITOMETER (GDC.10413) | KGI | 1990-07-09 | 76 |
| K901854 | GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412) | KGI | 1990-07-09 | 76 |
| K901848 | GADOLINIUM-153 BONE DENSITOMETER SOURCES | KGI | 1990-07-09 | 76 |
| K901832 | GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415 | KGI | 1990-07-09 | 76 |
| K896270 | AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081 | CHP | 1989-12-12 | 42 |
84 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Amersham 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.
- Amersham Health (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Amersham Corp.?
FDA lists 94 510(k) clearances under the applicant name “Amersham Corp.” (first 1976, latest 1992), across 41 product codes in 6 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 Amersham Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Amersham Corp. is 40 days.
Which FDA product codes appear under Amersham Corp.?
The most frequent FDA product codes under this applicant name are CDP (Radioimmunoassay, Total Triiodothyronine, 7); JJY (Multi-Analyte Controls, All Kinds (Assayed), 7); DBF (Ferritin, Antigen, Antiserum, Control, 6).
Next steps
- See all 94 Amersham Corp. clearances with predicates and recalls
- Run predicate analysis for product code CDP, Amersham 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.