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FDA 510(k) Application Details - K071930
Device Classification Name
Kit, Test, Pregnancy, Hcg, Over The Counter
More FDA Info for this Device
510(K) Number
K071930
Device Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant
BLUE CROSS BIO-MEDICAL CO., LTD.
BEIQIJA INDUSTRY ZONE
CHANGPING DISTRICT
BEIJING 102209 CN
Other 510(k) Applications for this Company
Contact
HILDA HONG YANG
Other 510(k) Applications for this Contact
Regulation Number
862.1155
More FDA Info for this Regulation Number
Classification Product Code
LCX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/13/2007
Decision Date
12/18/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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