Data / Medical devices / Assay, Glycosylated Hemoglobin

Assay, Glycosylated Hemoglobin (LCP): 49 FDA-registered makers in 13 countries

49 establishments in 13 countries are registered with the FDA to make Assay, Glycosylated Hemoglobin (product code LCP, Class 2, 21 CFR 864.7470). 30 of them have a 510(k) clearance or PMA approval on file and 7 have a recall event. The FDA has issued 249 510(k) clearances under this code, the latest on November 22, 2024, and lists 48 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

LCP

Device class

2

Regulation

864.7470

Medical specialty

Hematology

Makers by country

Makers of Assay, Glycosylated Hemoglobin

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.

Updated November 22, 2024. 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.