ACCU-CHEK SMART PIX

System, Test, Blood Glucose, Over The Counter

ROCHE DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Accu-chek Smart Pix.

Pre-market Notification Details

• Device ID: K062395
• 510k Number: K062395
• Device Name: ACCU-CHEK SMART PIX
• Classification: System, Test, Blood Glucose, Over The Counter
• Applicant: ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46256
• Contact: Scott Thiel
• Correspondent: Scott Thiel; ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46256
• Product Code: NBW
• Subsequent Product Code: JQP
• Subsequent Product Code: LZG
• CFR Regulation Number: 862.1345 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-08-16
• Decision Date: 2007-05-09
• Summary: summary