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FDA 510(k) Application Details - K013582
Device Classification Name
Radioimmunoassay, Luteinizing Hormone
More FDA Info for this Device
510(K) Number
K013582
Device Name
Radioimmunoassay, Luteinizing Hormone
Applicant
MAYBE?MOM
22 CHURCH ST.
SUITE 103-244
RAMSEY, NJ 07446 US
Other 510(k) Applications for this Company
Contact
TONI MILLERVA
Other 510(k) Applications for this Contact
Regulation Number
862.1485
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Classification Product Code
CEP
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More FDA Info for this Product Code
Date Received
10/30/2001
Decision Date
01/16/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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