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510(k) K121045

HUMAN ALBUMIN CSF KIT by The Binding Site Group , Ltd. — Product Code DCF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2013
Date Received
April 6, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Albumin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5040
Review Panel
IM
Submission Type

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