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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameinstrument, glucose, noninvasive technology
Generic Nameinstrument, glucose, noninvasive technology
200 lawrence dr.
west chester, PA 19380
PMA NumberP990026
Supplement NumberS020
Date Received08/01/2003
Decision Date08/20/2003
Product Code
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
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.