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Data / Medical devices / Colorimetric Method, Triglycerides

Colorimetric Method, Triglycerides (JGY): 26 FDA-registered makers in 7 countries

26 establishments in 7 countries are registered with the FDA to make Colorimetric Method, Triglycerides (product code JGY, Class 1, 21 CFR 862.1705). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 22 510(k) clearances under this code, the latest on April 24, 2012, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code
JGY
Device class
1
Regulation
862.1705
Medical specialty
Clinical Chemistry

Makers by country

CountryMakers
United States14
China5
South Korea3
Norway1
Egypt1
Taiwan1
Argentina1

Makers of Colorimetric Method, Triglycerides

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Polymer Technology SystemsWhitestown, IN, United StatesComplaint file establishment, Manufacturer2July 3, 2000000api.fda.gov
Bialex LabWichita Falls, TX, United StatesManufacturer1April 21, 1997000api.fda.gov
Abaxis, Inc.Union City, CA, United StatesManufacturer0000api.fda.gov
Acon Biotech (hangzhou) Co., Ltd.HANGZHOU Zhejiang, ChinaContract manufacturer0000api.fda.gov
Acon Laboratories, Inc.San Diego, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Abbott Diagnostics Technologies ASOslo, NorwayManufacturer0000api.fda.gov
Alere San Diego, Inc.San Diego, CA, United StatesManufacturer0000api.fda.gov
Biobase Biodustry(shandong)co., LtdJinan Shandong, ChinaManufacturer0000api.fda.gov
Dongguan Bao Kang Dian Zi Ke Ji LimitedDongguan City Guangdong, ChinaContract manufacturer0000api.fda.gov
Elhoda Trade And SuppliesBadr industerial city Al Qahirah, EgyptManufacturer0000api.fda.gov
East West WisconsinWhitewater, WI, United StatesContract manufacturer0000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesManufacturer0000api.fda.gov
Germaine Laboratories, Inc.San Antonio, TX, United StatesManufacturer, Remanufacturer0000api.fda.gov
Home Access Health Corp.Hoffman Est, IL, United StatesManufacturer0000api.fda.gov
Ixensor Co LtdTaipei, TaiwanManufacturer0000api.fda.gov
Nova Biomedical CorporationWaltham, MA, United StatesManufacturer for export0000api.fda.gov
Nova Biomedical CorporationBillerica, MA, United StatesManufacturer for export0000api.fda.gov
OSANG Healthcare CO., LTD.ANYANG Gyeonggi, South KoreaContract manufacturer0000api.fda.gov
Osang LLCS Pasadena, CA, United StatesContract manufacturer0000api.fda.gov
SD Biosensor, Inc.Suwon-si Gyeonggi, South KoreaSpecification developer0000api.fda.gov
SD Biosensor, Inc.Cheongju-si Chungbuk, South KoreaManufacturer0000api.fda.gov
Stanbio LaboratoryBoerne, TX, United StatesManufacturer0000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
URIT Medical Electronic Co., Ltd.Guilin Guangxi, ChinaManufacturer0000api.fda.gov
Wiener Laboratorios S.A.I.C.ROSARIO Santa Fe, ArgentinaManufacturer0000api.fda.gov
Zhejiang Orient Gene BiotechHuzhou Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov

Updated April 24, 2012. 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.