Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K150925
Device Classification Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
More FDA Info for this Device
510(K) Number
K150925
Device Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant
Immunalysis Corporation
829 Towne Center Drive
Pomona, CA 91767 US
Other 510(k) Applications for this Company
Contact
Joseph Ginete
Other 510(k) Applications for this Contact
Regulation Number
862.3250
More FDA Info for this Regulation Number
Classification Product Code
DIO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/06/2015
Decision Date
06/29/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact