CLEVER CHOICE

Glucose Oxidase, Glucose

SIMPLE DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Simple Diagnostics, Inc. with the FDA for Clever Choice.

Pre-market Notification Details

• Device ID: K120921
• 510k Number: K120921
• Device Name: CLEVER CHOICE
• Classification: Glucose Oxidase, Glucose
• Applicant: SIMPLE DIAGNOSTICS, INC. 8870 RAVELLO CT Naples, FL 34114
• Contact: Daniel Kamm
• Correspondent: Daniel Kamm; SIMPLE DIAGNOSTICS, INC. 8870 RAVELLO CT Naples, FL 34114
• Product Code: CGA
• Subsequent Product Code: JJX
• Subsequent Product Code: NBW
• CFR Regulation Number: 862.1345 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-03-27
• Decision Date: 2012-08-21
• Summary: summary