Data / Medical devices / System, Test, Low Density, Lipoprotein / United States
FDA-registered makers of System, Test, Low Density, Lipoprotein in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make System, Test, Low Density, Lipoprotein (product code MRR). 9 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 3, 2026.
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- Device
- System, Test, Low Density, Lipoprotein
- Product code
- MRR
- Country
- United States
Makers of System, Test, Low Density, Lipoprotein in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Cliniqa Corporation | San Marcos, CA, United States | Manufacturer, Repackager or relabeler | 2 | January 26, 2005 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer, Specification developer | 2 | July 26, 2024 | 0 | 1 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 2 | July 26, 2024 | 0 | 1 | 0 | api.fda.gov |
| Alfa Wassermann | West Caldwell, NJ, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 1 | July 13, 1999 | 0 | 0 | 0 | api.fda.gov |
| Horiba Instruments Incorporated | Canton, MI, United States | Manufacturer | 1 | July 22, 1998 | 0 | 0 | 0 | api.fda.gov |
| Medica Corp. | Bedford, MA, United States | Manufacturer | 1 | July 17, 2009 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Manufacturer, Repackager or relabeler | 1 | August 25, 2004 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | August 25, 2004 | 0 | 1 | 0 | api.fda.gov |
| Teco Diagnostics | Anaheim, CA, United States | Manufacturer | 1 | August 8, 2005 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Brea, CA, United States | Specification developer | 0 | 0 | 3 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| High Technology, Inc. | North Attleboro, MA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. 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.