FDA 510(k) Application Details - K080294

Device Classification Name	System,Test,Biotinidase   More FDA Info for this Device
510(K) Number	K080294
Device Name	System,Test,Biotinidase
Applicant	ASTORIA-PACIFIC,INC. 15130 S.E. 82ND DR. CLACKAMAS, OR 97015 US Other 510(k) Applications for this Company
Contact	JASON REYNOLDS 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	02/04/2008
Decision Date	11/04/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review