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FDA 510(k) Application Details - K090123
Device Classification Name
System,Test,Biotinidase
More FDA Info for this Device
510(K) Number
K090123
Device Name
System,Test,Biotinidase
Applicant
PERKINELMER, INC.
8275 CARLOWAY ROAD
INDIANAPOLIS, IN 46236 US
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Contact
KAY A TAYLOR
Other 510(k) Applications for this Contact
Regulation Number
862.1118
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Classification Product Code
NAK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/21/2009
Decision Date
03/05/2010
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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