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FDA 510(k) Application Details - K103574
Device Classification Name
Kit, Test, Pregnancy, Hcg, Over The Counter
More FDA Info for this Device
510(K) Number
K103574
Device Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant
Lehnus & Associates Consulting
150 CHERRY LANE RD.
EAST STROUDSBURG, PA 18301-8804 US
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Contact
Gary Lehnus
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
12/06/2010
Decision Date
07/28/2011
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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