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FDA 510(k) Application Details - K013907
Device Classification Name
Kit, Test, Pregnancy, Hcg, Over The Counter
More FDA Info for this Device
510(K) Number
K013907
Device Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant
CAMBRIDGE DIAGNOSTICS IRELAND, LTD.
MERVUE BUSINESS PARK
GALWAY IE
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Contact
AVRIL MURRAY
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
11/26/2001
Decision Date
12/18/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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