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510(k) K090123

NEONATAL BIOTINIDASE KIT, MODEL 3018 by Perkinelmer, Inc. — Product Code NAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2010
Date Received
January 21, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Biotinidase
Device Class
Class II
Regulation Number
862.1118
Review Panel
CH
Submission Type

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