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510(k) K120901

HUMAN IGA CSF KIT FOR USE ON SPAPLUS by The Binding Site Group , Ltd. — Product Code CFN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2013
Date Received
March 26, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Method, Nephelometric, Immunoglobulins (G, A, M)
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

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