Data / Medical devices / Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (CIN): 7 FDA-registered makers in 4 countries
7 establishments in 4 countries are registered with the FDA to make Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (product code CIN, Class 2, 21 CFR 862.1050). 6 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 26 510(k) clearances under this code, the latest on April 15, 2024, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- CIN
- Device class
- 2
- Regulation
- 862.1050
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| United Kingdom | 1 |
| Finland | 1 |
| France | 1 |
Makers of Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Helena Laboratories, Corp. | Beaumont, TX, United States | Manufacturer | 3 | May 6, 2002 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Chaska, MN, United States | Manufacturer | 2 | April 15, 2024 | 0 | 0 | 0 | api.fda.gov |
| Immunodiagnostic Systems Ltd. | Boldon Colliery Durham, United Kingdom | Manufacturer | 2 | September 30, 2020 | 0 | 1 | 0 | api.fda.gov |
| Aidian OY | ESPOO Uusimaa, Finland | Manufacturer | 1 | May 4, 2005 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Athens, OH, United States | Complaint file establishment, Manufacturer | 1 | May 27, 1998 | 0 | 1 | 0 | api.fda.gov |
| Sebia | EVRY Essonne, France | Manufacturer | 1 | June 13, 2001 | 0 | 0 | 0 | api.fda.gov |
| Diasorin Inc. | Stillwater, MN, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 15, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.