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Data / Medical devices / Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides / United States

FDA-registered makers of Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides in the United States: 17 establishments

17 establishments in the United States are registered with the FDA to make Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides (product code CDT). 11 have a 510(k) clearance or PMA approval on file and 6 have a recall event. FDA data exported November 2, 2026.

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Device
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Product code
CDT
Country
United States

Makers of Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer3November 22, 2013020api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer, Manufacturer, Manufacturer for export2August 5, 1996000api.fda.gov
Horiba Instruments IncorporatedCanton, MI, United StatesManufacturer2July 22, 1986000api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer, Specification developer2January 18, 2005030api.fda.gov
Teco DiagnosticsAnaheim, CA, United StatesManufacturer2March 15, 1988000api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesSpecification developer1January 28, 1992040api.fda.gov
Cliniqa CorporationSan Marcos, CA, United StatesManufacturer1July 9, 1984000api.fda.gov
Carolina Liquid ChemistriesBrea, CA, United StatesManufacturer1March 13, 1987000api.fda.gov
Infrared Laboratory Systems dba SYNERMEDWestfield, IN, United StatesManufacturer1July 27, 1990000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer1May 31, 2013010api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer1May 31, 2013010api.fda.gov
Abbott LaboratoriesIrving, TX, United StatesSpecification developer0000api.fda.gov
Alfa WassermannWest Caldwell, NJ, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0010api.fda.gov
High Technology, Inc.North Attleboro, MA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Medica Corp.Bedford, MA, United StatesManufacturer0000api.fda.gov
Stanbio LaboratoryBoerne, TX, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov

Updated November 2, 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.