Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K133343
Device Classification Name
Antigens, All Groups, Streptococcus Spp.
More FDA Info for this Device
510(K) Number
K133343
Device Name
Antigens, All Groups, Streptococcus Spp.
Applicant
Guangzhou Wondfo Biotech Co., Ltd.
504 EAST DIAMOND AVE.
SUITE F
GAITHERSBURG, MD 20878 US
Other 510(k) Applications for this Company
Contact
Joe Shia
Other 510(k) Applications for this Contact
Regulation Number
866.3740
More FDA Info for this Regulation Number
Classification Product Code
GTY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/30/2013
Decision Date
01/31/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact