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FDA 510(k) Application Details - K082488
Device Classification Name
Lipoprotein, Low-Density, Antigen, Antiserum, Control
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510(K) Number
K082488
Device Name
Lipoprotein, Low-Density, Antigen, Antiserum, Control
Applicant
GENERAL ATOMICS
12889 GREGG COURT
POWAY, CA 92064 US
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Contact
Abhijit Datta
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Regulation Number
866.5600
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Classification Product Code
DFC
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More FDA Info for this Product Code
Date Received
08/28/2008
Decision Date
01/13/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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