PMA P990026S020

Device: GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER
Applicant: Animas Corp.
PMA number: P990026
Supplement: S020
Product code: NCT
Decision date: 2003-08-20
Classification: Clinical Chemistry
Generic name: INSTRUMENT, GLUCOSE, NONINVASIVE TECHNOLOGY
Approval order statement: CHANGE TO THE MANUFACTURING PROCESS OF THE GLUCOWATCH BIOGRAPHER AUTOSENSOR TO ADD A SECONDARY VISUAL INSPECTION OF THE AUTOSENSORS REJECTED BY THE AUTOMATED, CAMERA-BASED INSPECTION TO INCREASE PRODUCT YIELD AND REDUCE PRODUCTION COSTS.

Current openFDA PMA Record#

Device: GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER
Applicant: Animas Corp.
PMA number: P990026
Supplement: S020
Product code: NCT
Generic name: INSTRUMENT, GLUCOSE, NONINVASIVE TECHNOLOGY
Decision date: 2003-08-20
Decision code: OK30
Date received: 2003-08-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO THE MANUFACTURING PROCESS OF THE GLUCOWATCH BIOGRAPHER AUTOSENSOR TO ADD A SECONDARY VISUAL INSPECTION OF THE AUTOSENSORS REJECTED BY THE AUTOMATED, CAMERA-BASED INSPECTION TO INCREASE PRODUCT YIELD AND REDUCE PRODUCTION COSTS.