Medical device manufacturer
Amersham Corp.
Amersham Corp. holds 94 FDA 510(k) clearances across 40 product codes. Median elapsed review time is 39 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 94
- Product codes
- 40
- Median review
- 39 days
- Recall records
- 0
How does FDA spell Amersham Corp.?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Amersham Corp. file in?
40 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| CDP | Radioimmunoassay, Total Triiodothyronine | 7 | 54 days | |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 7 | 57 days | |
| DBF | Ferritin, Antigen, Antiserum, Control | 6 | 21 days | |
| CEC | Radioimmunoassay, Free Thyroxine | 5 | 46 days | |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 5 | 40 days | |
| CEP | Radioimmunoassay, Luteinizing Hormone | 4 | 22 days | |
| CGI | Radioimmunoassay, Estriol | 4 | 19 days | |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 4 | 33 days | |
| JLS | Radioimmunoassay, Progesterone | 4 | 42 days | |
| KGI | Densitometer, Bone | 4 | 76 days | |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 3 | 49 days | |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 3 | 28 days | |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 3 | 32 days | |
| KHQ | Radioassay, Triiodothyronine Uptake | 3 | 59 days | |
| CGN | Acid, Folic, Radioimmunoassay | 2 | 17 days | |
| CGR | Radioimmunoassay, Cortisol | 2 | 19 days | |
| CHP | Radioimmunoassay, Estradiol | 2 | 42 days | |
| IWJ | System, Applicator, Radionuclide, Manual | 2 | 19 days | |
| CDD | Radioassay, Vitamin B12 | 1 | 29 days | |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 23 days | |
| CEE | Radioimmunoassay, Thyroxine-Binding Globulin | 1 | 103 days | |
| CHO | Radioimmunoassay, Cyclic Amp | 1 | 49 days | |
| CIG | Diazo Colorimetry, Bilirubin | 1 | 32 days | |
| DIF | Drug Mixture Control Materials | 1 | 14 days | |
| DLP | Radioimmunoassay, Diphenylhydantoin | 1 | 49 days |
Showing the 25 they file in most, of 40.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Amersham Corp. had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Amersham Corp. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K914135 | AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086 | CFT | 155 | |
| K912733 | AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT | CIG | 32 | |
| K912766 | AMERLITE CK-MB ASSAY | JHY | 23 | |
| K904666 | AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008 | JLW | 18 | |
| K902760 | AMERSHAM TSH CONTROL SERA | JJX | 32 | |
| K901857 | GADOLINIUM-153 BONE DENSITOMETER (GDC.10413) | KGI | 76 | |
| K901854 | GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412) | KGI | 76 | |
| K901848 | GADOLINIUM-153 BONE DENSITOMETER SOURCES | KGI | 76 | |
| K901832 | GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415 | KGI | 76 | |
| K896270 | AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081 | CHP | 42 |
Source: openFDA device/510k · retrieved
Watch what Amersham Corp. files next
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