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Data / Medical devices / United States / Glytec, LLC

Glytec, LLC: FDA-registered device maker in Greenville, SC, United States, 4 510(k) clearances

Glytec, LLC is registered with the FDA (registration 3005853093) in Greenville, SC, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated May 27, 2026. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number
3005853093
Address
220 N Main St, Greenville, SC, United States, 29601
Owner or operator
Glytec, LLC (9090324)
Roles
Manufacturer
First device listed
December 24, 2010
Registered through
2026
Brand names listed
G+, G+ Enterprise System, Glucommander

Devices it lists

DeviceProduct codeClassRoleSource
Calculator, Drug DoseNDC2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 27, 2026K254102GlucommanderNDCSubstantially EquivalentGlytec, LLCaccessdata.fda.gov
August 4, 2017K152300GlucommanderNDCSubstantially EquivalentGlytec, LLCaccessdata.fda.gov
May 8, 2012K113853G+ SYSTEMNDCSubstantially EquivalentGlytec, LLCaccessdata.fda.gov
June 28, 2010K101344G+ SYSTEMNDCSubstantially EquivalentGlytec, LLC (Formally Known AS Glucotec, Inc.)accessdata.fda.gov

Compare with other makers

Updated May 27, 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.