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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Drug Dose
510(k) Number K261939
Device Name Glucommander
Applicant
Glytec, LLC
200 N Main St.
Greenville,  SC  29601
Applicant Contact Rachel Hofmann
Correspondent
Glytec, LLC
200 N Main St.
Greenville,  SC  29601
Correspondent Contact Rachel Hofmann
Regulation Number868.1890
Classification Product Code
NDC  
Date Received06/10/2026
Decision Date 10/05/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Clinical Chemistry
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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