Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K151478
Device Classification Name
Enzyme Immunoassay, Opiates
More FDA Info for this Device
510(K) Number
K151478
Device Name
Enzyme Immunoassay, Opiates
Applicant
GUANGZHOU WONDFO BIOTECH CO., LTD.
WONDFO SCIENTECH PARK, SOUTH CHINA UNIV. OF TECHNOLOGY
GUANGZHOU 510641 CN
Other 510(k) Applications for this Company
Contact
BEN CHEN
Other 510(k) Applications for this Contact
Regulation Number
862.3650
More FDA Info for this Regulation Number
Classification Product Code
DJG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/02/2015
Decision Date
07/01/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact