CHOL

Enzymatic Esterase--oxidase, Cholesterol

ABBOTT LABORATORIES

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

Pre-market Notification Details

• Device ID: K981652
• 510k Number: K981652
• Device Name: CHOL
• Classification: Enzymatic Esterase--oxidase, Cholesterol
• Applicant: ABBOTT LABORATORIES DEPT. 09VA LC-2 1920 HURD DRIVE Irving, TX 75038
• Contact: Mark Littlefield
• Correspondent: Mark Littlefield; ABBOTT LABORATORIES DEPT. 09VA LC-2 1920 HURD DRIVE Irving, TX 75038
• Product Code: CHH
• CFR Regulation Number: 862.1175 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-05-11
• Decision Date: 1998-06-29
• Summary: summary