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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.
 
Trade NameGLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER
Classification Nameglucose oxidase, glucose
Generic Nameinstrument, glucose, noninvasive technology\
Regulation Number862.1345
ApplicantCYGNUS, INC.
PMA NumberP990026
Supplement NumberS010
Date Received11/19/2001
Decision Date11/30/2001
Product Code
CGA[ Registered Establishments with CGA ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for extended shelf life of the qc test solution from 6 months to 24 months.
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