Glucommander

Calculator, Drug Dose

GLYTEC, LLC

The following data is part of a premarket notification filed by Glytec, Llc with the FDA for Glucommander.

Pre-market Notification Details

• Device ID: K152300
• 510k Number: K152300
• Device Name: Glucommander
• Classification: Calculator, Drug Dose
• Applicant: GLYTEC, LLC 770 PELHAM ROAD, SUITE 210 Greenville, SC 29615
• Contact: Julie Glendrange
• Correspondent: Julie Glendrange; GLYTEC, LLC 770 PELHAM ROAD, SUITE 210 Greenville, SC 29615
• Product Code: NDC
• CFR Regulation Number: 868.1890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-08-14
• Decision Date: 2017-08-04
• Summary: summary