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FDA 510(k) Application Details - K013359
Device Classification Name
Lipoprotein, Low-Density, Antigen, Antiserum, Control
More FDA Info for this Device
510(K) Number
K013359
Device Name
Lipoprotein, Low-Density, Antigen, Antiserum, Control
Applicant
DENKA SEIKEN'S
3-4-2 NIHONBASHI
KAYABACHO, CHUO-KU
TOKYO 103-0025 JP
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Contact
YOUSUKE MEGURO
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
10/10/2001
Decision Date
03/08/2002
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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