PMA P990026S021

Device: GLUCOWATCH G2 BIOGRAPHER
Applicant: Animas Corp.
PMA number: P990026
Supplement: S021
Product code: NCT
Decision date: 2004-02-25
Classification: Clinical Chemistry
Generic name: INSTRUMENT, GLUCOSE, NONINVASIVE TECHNOLOGY
Approval order statement: APPROVAL FOR AN EXPANSION OF THE LABELING TO INCLUDE A DESCRIPTION OF PRE-TREATMENT PRODUCTS AND A METHOD TO MINIMIZE THE AFFECTS OF SKIN IRRITATION WITHOUT AFFECTING THE ACCURACY OF G2 BIOGRAPHER GLUCOSE MEASUREMENTS.

Current openFDA PMA Record#

Device: GLUCOWATCH G2 BIOGRAPHER
Applicant: Animas Corp.
PMA number: P990026
Supplement: S021
Product code: NCT
Generic name: INSTRUMENT, GLUCOSE, NONINVASIVE TECHNOLOGY
Decision date: 2004-02-25
Decision code: APPR
Date received: 2003-10-01
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR AN EXPANSION OF THE LABELING TO INCLUDE A DESCRIPTION OF PRE-TREATMENT PRODUCTS AND A METHOD TO MINIMIZE THE AFFECTS OF SKIN IRRITATION WITHOUT AFFECTING THE ACCURACY OF G2 BIOGRAPHER GLUCOSE MEASUREMENTS.