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Data / Medical devices / Conversion To Creatinine, Creatine

Conversion To Creatinine, Creatine (JLA): 5 FDA-registered makers in 3 countries

5 establishments in 3 countries are registered with the FDA to make Conversion To Creatinine, Creatine (product code JLA, Class 1, 21 CFR 862.1210). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on November 13, 1986, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code
JLA
Device class
1
Regulation
862.1210
Medical specialty
Clinical Chemistry

Makers by country

CountryMakers
China3
France1
Egypt1

Makers of Conversion To Creatinine, Creatine

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
Diagnostica Stago - TavernyTaverny Val-d'Oise, FranceExporter to the US, Manufacturer1January 3, 1986000api.fda.gov
Changchun Merydi Bio-Tech Co., Ltd.changchun Jilin, ChinaManufacturer0000api.fda.gov
Changchun Wancheng Bio-Electron Co., Ltd.Changchun Jilin, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Elhoda Trade And SuppliesBadr industerial city Al Qahirah, EgyptManufacturer0000api.fda.gov
Jilin Hongyi Bio-Tech Co., Ltd.Changchun Jilin, ChinaExporter to the US, Manufacturer0000api.fda.gov

Updated November 13, 1986. 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.