ETHANOL

Nad-nadh, Specific Reagent For Alcohol Enzyme Method

ABBOTT LABORATORIES

The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Ethanol.

Pre-market Notification Details

• Device ID: K013538
• 510k Number: K013538
• Device Name: ETHANOL
• Classification: Nad-nadh, Specific Reagent For Alcohol Enzyme Method
• Applicant: ABBOTT LABORATORIES 1920 HURD DRIVE, MS 8-21 Irving, TX 75038
• Contact: Alicia Simpson
• Correspondent: Alicia Simpson; ABBOTT LABORATORIES 1920 HURD DRIVE, MS 8-21 Irving, TX 75038
• Product Code: DML
• CFR Regulation Number: 862.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-10-24
• Decision Date: 2001-12-14
• Summary: summary