FDA 510(k) Application Details - DEN990008

Device Classification Name	System,Test,Biotinidase   More FDA Info for this Device
510(K) Number	DEN990008
Device Name	System,Test,Biotinidase
Applicant	WALLAC, INC. 3985 EASTERN RD. NORTON, OH 44203 US Other 510(k) Applications for this Company
Contact	CARROLL L MARTIN Other 510(k) Applications for this Contact
Regulation Number	862.1118   More FDA Info for this Regulation Number
Classification Product Code	NAK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/1999
Decision Date	02/15/2000
Decision	DENG -
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review