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Data / Medical devices / Enzymatic Esterase--Oxidase, Cholesterol / United States

FDA-registered makers of Enzymatic Esterase--Oxidase, Cholesterol in the United States: 34 establishments

34 establishments in the United States are registered with the FDA to make Enzymatic Esterase--Oxidase, Cholesterol (product code CHH). 17 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 3, 2026.

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Device
Enzymatic Esterase--Oxidase, Cholesterol
Product code
CHH
Country
United States

Makers of Enzymatic Esterase--Oxidase, Cholesterol in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Polymer Technology SystemsWhitestown, IN, United StatesComplaint file establishment, Manufacturer6December 22, 2016050api.fda.gov
Alfa WassermannWest Caldwell, NJ, United StatesComplaint file establishment, Repackager or relabeler, Specification developer3October 5, 2012000api.fda.gov
Cliniqa CorporationSan Marcos, CA, United StatesManufacturer2September 24, 1997000api.fda.gov
Horiba Instruments IncorporatedCanton, MI, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler2July 22, 1983000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer2September 29, 2015000api.fda.gov
Teco DiagnosticsAnaheim, CA, United StatesManufacturer2January 30, 1992000api.fda.gov
Abaxis, Inc.Union City, CA, United StatesManufacturer1April 13, 1995000api.fda.gov
Abbott LaboratoriesIrving, TX, United StatesSpecification developer1June 29, 1998000api.fda.gov
Acon Laboratories, Inc.San Diego, CA, United StatesManufacturer, Specification developer1July 11, 2017000api.fda.gov
Bialex LabWichita Falls, TX, United StatesManufacturer1April 22, 1987000api.fda.gov
Chematics, Inc.North Webster, IN, United StatesContract manufacturer, Manufacturer1June 10, 1988000api.fda.gov
Carolina Liquid ChemistriesBrea, CA, United StatesManufacturer1June 20, 1997000api.fda.gov
Infrared Laboratory Systems dba SYNERMEDWestfield, IN, United StatesManufacturer1October 1, 1990000api.fda.gov
Medica Corp.Bedford, MA, United StatesManufacturer1February 20, 2008000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer1March 27, 2019010api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer1March 27, 2019000api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer, Specification developer1June 11, 1986010api.fda.gov
Alere San Diego, Inc.San Diego, CA, United StatesManufacturer0010api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesSpecification developer0040api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
BiometerPlus USA, Inc.Fremont, CA, United StatesManufacturer0000api.fda.gov
ELITechGroup IncLogan, UT, United StatesContract manufacturer0000api.fda.gov
East West WisconsinWhitewater, WI, United StatesContract manufacturer0000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer, Manufacturer, Manufacturer for export0000api.fda.gov
Germaine Laboratories, Inc.San Antonio, TX, United StatesManufacturer, Remanufacturer0000api.fda.gov
Home Access Health Corp.Hoffman Est, IL, United StatesManufacturer0000api.fda.gov
High Technology, Inc.North Attleboro, MA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Nova Biomedical CorporationWaltham, MA, United StatesManufacturer for export0000api.fda.gov
Nova Biomedical Corporation Diabetes ProductsBillerica, MA, United StatesManufacturer for export0000api.fda.gov
Nova Biomedical CorporationBillerica, MA, United StatesManufacturer for export0000api.fda.gov
Nova Biomedical CorporationBillerica, MA, United StatesManufacturer for export0000api.fda.gov
Osang LLCS Pasadena, CA, United StatesContract manufacturer0000api.fda.gov
Scientific Supplies & Technology, Inc.Doral, FL, United StatesRemanufacturer, Repackager or relabeler0000api.fda.gov
Stanbio LaboratoryBoerne, TX, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.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.