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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 Nameglucose oxidase, glucose
Generic Nameglucose oxidase, glucose
Regulation Number862.1345
200 lawrence dr.
west chester, PA 19380
PMA NumberP990026
Supplement NumberS007
Date Received08/28/2001
Decision Date10/25/2001
Product Code
CGA[ Registered Establishments with CGA ]
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the manufacturing facility located at cygnus, inc. , redwood, california.