510(k) K254102
K254102 is an FDA 510(k) premarket notification submitted by Glytec, LLC for the device "Glucommander". The FDA issued a decision of Substantially Equivalent on May 27, 2026. The device falls under product code NDC (Calculator, Drug Dose), a Class II device regulated under 21 CFR 868.1890. Glytec, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 27, 2026
- Date Received
- December 19, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calculator, Drug Dose
- Device Class
- Class II
- Regulation Number
- 868.1890
- Review Panel
- CH
- Submission Type