PRODIGY

System, Test, Blood Glucose, Over The Counter

DIAGNOSTIC DEVICES INC.

The following data is part of a premarket notification filed by Diagnostic Devices Inc. with the FDA for Prodigy.

Pre-market Notification Details

• Device ID: K053593
• 510k Number: K053593
• Device Name: PRODIGY
• Classification: System, Test, Blood Glucose, Over The Counter
• Applicant: DIAGNOSTIC DEVICES INC. PO BOX 7007 Deerfield, IL 60015
• Contact: Daniel Kamm
• Correspondent: Daniel Kamm; DIAGNOSTIC DEVICES INC. PO BOX 7007 Deerfield, IL 60015
• Product Code: NBW
• Subsequent Product Code: CGA
• Subsequent Product Code: JJX
• CFR Regulation Number: 862.1345 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-12-23
• Decision Date: 2006-07-06
• Summary: summary