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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 system, test, biotinidase
De Novo Number DEN990008
510(K) Number K992284
Device Name WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000
Requester
wallac, inc.
3985 eastern rd.
norton,  OH  44203
Contact carroll l martin
Regulation Number862.1118
Classification Product Code
NAK  
Date Received12/20/1999
Decision Date 02/15/2000
Decision granted (DENG)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Classification Order Classification Order
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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