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FDA 510(k) Application Details - K992662
Device Classification Name
Apolipoproteins
More FDA Info for this Device
510(K) Number
K992662
Device Name
Apolipoproteins
Applicant
BAYER CORP.
511 BENEDICT AVE.
TARRYTOWN, NY 10591-5097 US
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Contact
GABRIEL J MURACA
Other 510(k) Applications for this Contact
Regulation Number
862.1475
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Classification Product Code
MSJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/09/1999
Decision Date
02/15/2000
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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