PMA P990026S017

Device: GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER
Applicant: Animas Corp.
PMA number: P990026
Supplement: S017
Product code: CGA
Decision date: 2003-06-17
Classification: Clinical Chemistry
Generic name: GLUCOSE OXIDASE, GLUCOSE
Approval order statement: CHANGE TO AN EQUIVALENT IN-HOUSE SUPPLIER OF THE RAW MATERIAL PLATINUM/CARBON (PT/C) COMPOSITE ELECTRODE INK FOR THE MANUFACTURE OF THE GLUCOWATCH BIOGRAPHER AUTOSENSOR.

Current openFDA PMA Record#

Device: GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER
Applicant: Animas Corp.
PMA number: P990026
Supplement: S017
Product code: CGA
Generic name: GLUCOSE OXIDASE, GLUCOSE
Decision date: 2003-06-17
Decision code: OK30
Date received: 2003-06-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO AN EQUIVALENT IN-HOUSE SUPPLIER OF THE RAW MATERIAL PLATINUM/CARBON (PT/C) COMPOSITE ELECTRODE INK FOR THE MANUFACTURE OF THE GLUCOWATCH BIOGRAPHER AUTOSENSOR.