PRODIGY CHOICE

System, Test, Blood Glucose, Over The Counter

PRODIGY DIABETES CARE, LLC

The following data is part of a premarket notification filed by Prodigy Diabetes Care, Llc with the FDA for Prodigy Choice.

Pre-market Notification Details

• Device ID: K122340
• 510k Number: K122340
• Device Name: PRODIGY CHOICE
• Classification: System, Test, Blood Glucose, Over The Counter
• Applicant: PRODIGY DIABETES CARE, LLC 1468 Harwell Avenue Crofton, MD 21114
• Contact: E J Smith
• Correspondent: E J Smith; PRODIGY DIABETES CARE, LLC 1468 Harwell Avenue Crofton, MD 21114
• Product Code: NBW
• CFR Regulation Number: 862.1345 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-08-02
• Decision Date: 2013-11-26
• Summary: summary