Data / Medical devices / Assay, Glycosylated Hemoglobin / United States
FDA-registered makers of Assay, Glycosylated Hemoglobin in the United States: 23 establishments
23 establishments in the United States are registered with the FDA to make Assay, Glycosylated Hemoglobin (product code LCP). 18 have a 510(k) clearance or PMA approval on file and 6 have a recall event. FDA data exported November 3, 2026.
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- Device
- Assay, Glycosylated Hemoglobin
- Product code
- LCP
- Country
- United States
Makers of Assay, Glycosylated Hemoglobin in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Manufacturer, Manufacturer for export, Specification developer | 12 | June 25, 2014 | 0 | 18 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 7 | January 24, 2014 | 0 | 4 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc | East Walpole, MA, United States | Complaint file establishment, Specification developer | 4 | October 9, 2007 | 0 | 0 | 0 | api.fda.gov |
| Teco Diagnostics | Anaheim, CA, United States | Manufacturer, Repackager or relabeler | 4 | August 8, 2005 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Brea, CA, United States | Manufacturer, Specification developer | 3 | July 14, 2014 | 0 | 1 | 0 | api.fda.gov |
| Diazyme Laboratories, Inc. | Poway, CA, United States | Manufacturer | 3 | November 21, 2016 | 0 | 0 | 0 | api.fda.gov |
| Horiba Instruments Incorporated | Canton, MI, United States | Manufacturer | 3 | August 6, 2003 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics, Inc. | Mishawaka, IN, United States | Manufacturer | 2 | May 5, 1995 | 0 | 0 | 0 | api.fda.gov |
| Alfa Wassermann | West Caldwell, NJ, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 1 | August 6, 2012 | 0 | 1 | 0 | api.fda.gov |
| Home Access Health Corp. | Hoffman Est, IL, United States | Manufacturer | 1 | March 13, 2015 | 0 | 0 | 0 | api.fda.gov |
| Medica Corp. | Bedford, MA, United States | Manufacturer | 1 | May 14, 2012 | 0 | 0 | 0 | api.fda.gov |
| Neelyx Labs | Wood Dale, IL, United States | Manufacturer, Repackager or relabeler | 1 | January 22, 2002 | 0 | 0 | 0 | api.fda.gov |
| Nova Biomedical Corporation | Waltham, MA, United States | Complaint file establishment, Manufacturer | 1 | November 22, 2024 | 0 | 0 | 0 | api.fda.gov |
| Nova Biomedical Corporation | Billerica, MA, United States | Manufacturer, Manufacturer for export, Remanufacturer | 1 | November 22, 2024 | 0 | 0 | 0 | api.fda.gov |
| Polymer Technology Systems | Whitestown, IN, United States | Manufacturer | 1 | May 14, 2009 | 0 | 2 | 0 | api.fda.gov |
| Qurasense, Inc. | Menlo Park, CA, United States | Manufacturer | 1 | December 6, 2023 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer, Specification developer | 1 | January 8, 2009 | 0 | 6 | 0 | api.fda.gov |
| Trinity Biotech (Primus Corporation dba Trinity Biotech) | Kansas City, MO, United States | Manufacturer | 1 | November 22, 2011 | 0 | 0 | 0 | api.fda.gov |
| Abbott Laboratories | Irving, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alere San Diego, Inc. | San Diego, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fisher Diagnostics | Middletown, VA, 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.