DIRECT

Glucose Oxidase, Glucose

UNIVERSITY OF WISCONSIN

The following data is part of a premarket notification filed by University Of Wisconsin with the FDA for Direct.

Pre-market Notification Details

• Device ID: K852960
• 510k Number: K852960
• Device Name: DIRECT
• Classification: Glucose Oxidase, Glucose
• Applicant: UNIVERSITY OF WISCONSIN 600 HIGHLAND AVE. Madison, WI 53792
• Contact: Stuart J Updike
• Correspondent: Stuart J Updike; UNIVERSITY OF WISCONSIN 600 HIGHLAND AVE. Madison, WI 53792
• Product Code: CGA
• CFR Regulation Number: 862.1345 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-07-12
• Decision Date: 1986-06-16