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510(k) K071961

MESACUP MODELS BP180 AND BP230 ELISA KITS by Mbl International Corporation — Product Code OEG

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 25, 2008
Date Received: July 16, 2007
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230
Device Class: Class II
Regulation Number: 866.5660
Review Panel: IM
Submission Type

The device is intended as an aid in the diagnosis of bullous pemphigoid.