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FDA 510(k) Application Details - K110889
Device Classification Name
Kit, Test, Pregnancy, Hcg, Over The Counter
More FDA Info for this Device
510(K) Number
K110889
Device Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant
IND DIAGNOSTICS INC.
1629 FOSTERS WAY
DELTA, BRITISH COLUMBIA V3M 6S7 CA
Other 510(k) Applications for this Company
Contact
KAI LOU
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
03/30/2011
Decision Date
06/20/2011
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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