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FDA 510(k) Application Details - K992665
Device Classification Name
Lipoprotein, Low-Density, Antigen, Antiserum, Control
More FDA Info for this Device
510(K) Number
K992665
Device Name
Lipoprotein, Low-Density, Antigen, Antiserum, Control
Applicant
TRINITY BIOTECH USA
P.O. BOX 1059
JAMESTOWN, NY 14702-1059 US
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Contact
WAYNE A KVETKOSKY
Other 510(k) Applications for this Contact
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
08/09/1999
Decision Date
11/26/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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