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FDA 510(k) Application Details - K093032
Device Classification Name
Multi-Analyte Controls, All Kinds (Assayed)
More FDA Info for this Device
510(K) Number
K093032
Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Applicant
BIOSITE INCORPORATED
9975 SUMMERS RIDGE RD
SAN DIEGO, CA 92121 US
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Contact
MARA CALER
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Regulation Number
862.1660
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Classification Product Code
JJY
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More FDA Info for this Product Code
Date Received
09/29/2009
Decision Date
11/13/2009
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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