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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name antigen, invasive fungal pathogens
De Novo Number DEN040003
510(K) Number K032373
Device Name GLUCATELL
Requester
associates of cape cod, inc.
1738 tamberwood echo
woodbury,  MN  55125
Contact stacy suberg
Regulation Number866.3050
Classification Product Code
NQZ  
Date Received03/22/2004
Decision Date 05/21/2004
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Classification Order Classification Order
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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