Data / Medical devices / Anti-Sm Antibody, Antigen And Control
Anti-Sm Antibody, Antigen And Control (LKP): 11 FDA-registered makers in 4 countries
11 establishments in 4 countries are registered with the FDA to make Anti-Sm Antibody, Antigen And Control (product code LKP, Class 2, 21 CFR 866.5100). 5 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 28 510(k) clearances under this code, the latest on July 14, 2021, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LKP
- Device class
- 2
- Regulation
- 866.5100
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Germany | 3 |
| Sweden | 2 |
| France | 1 |
Makers of Anti-Sm Antibody, Antigen And Control
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 |
|---|---|---|---|---|---|---|---|---|
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | April 20, 1994 | 0 | 0 | 0 | api.fda.gov |
| Inova Diagnostics, Inc. | San Diego, CA, United States | Manufacturer | 1 | April 17, 2013 | 0 | 0 | 0 | api.fda.gov |
| Phadia AB | Uppsala, Sweden | Complaint file establishment, Manufacturer | 1 | July 14, 2021 | 0 | 1 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 1 | June 25, 1984 | 0 | 0 | 0 | api.fda.gov |
| Theratest Laboratories, Inc. | Lombard, IL, United States | Manufacturer | 1 | October 7, 2005 | 0 | 0 | 0 | api.fda.gov |
| Euroimmun Medizinische Labordiagnostika AG | Luebeck Schleswig-Holstein, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EUROIMMUN Medizinische Labordiagnostika AG | Dassow Mecklenburg-Western Pomerania, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immco Diagnostics, Inc. | Williamsville, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phadia AB | Uppsala, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phadia GMBH | FREIBURG Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Theradiag | MARNE LA VALLEE CEDEX 2 Seine-et-Marne, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 14, 2021. 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.