Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER |
Generic Name | GLUCOSE OXIDASE, GLUCOSE |
Regulation Number | 862.1345 |
Applicant | ANIMAS CORP. 200 LAWRENCE DR. WEST CHESTER, PA 19380 |
PMA Number | P990026 |
Supplement Number | S010 |
Date Received | 11/19/2001 |
Decision Date | 11/30/2001 |
Withdrawal Date
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04/23/2010 |
Product Code |
CGA |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
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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