Glucose Oxidase, Glucose

Basic Information

• Device Name: Glucose Oxidase, Glucose
• Trade Name: GLUCOWATCH(R) AUTOMATIC GLUCOSE BIOGRAPHER
• PMA Number: P990026
• Supplement Number: S005
• Device Class: FDA Class 2
• Product Code: CGA
• Generic Name: GLUCOSE OXIDASE, GLUCOSE
• Regulation Number: 862.1345
• Medical Specialty: Clinical Chemistry
• Advisory Committee: Clinical Chemistry
• Decision: Approved
• Decision Code: APPR
• Decision Date: August 28, 2001
• Date Received: August 7, 2001
• Supplement Type: Real-Time Process
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review: N

Advisory Committee Statement

APPROVAL FOR MODIFICATIONS TO THE LABELING FOR THE GLUCOWATCH(R) AUTOMATIC GLUCOSE BIOGRAPHER.

Classifications

This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

Product Code	Device Name	Device Class	Medical Specialty
CGA	Glucose Oxidase, Glucose	FDA class 2	Clinical Chemistry

Applicant

• Name: ANIMAS CORP.
• Address: 200 LAWRENCE DR., WEST CHESTER, PA, 19380