FDA 510(k) Application Details - K110515

Device Classification Name	Enzyme Immunoassay, Barbiturate   More FDA Info for this Device
510(K) Number	K110515
Device Name	Enzyme Immunoassay, Barbiturate
Applicant	UCP BIOSCIENCES, INC. 1445 KOLL CIRCLE, STE. 111 SAN JOSE, CA 95112 US Other 510(k) Applications for this Company
Contact	NANCY CHEN Other 510(k) Applications for this Contact
Regulation Number	862.3150   More FDA Info for this Regulation Number
Classification Product Code	DIS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/23/2011
Decision Date	04/20/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
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