Cleared Traditional

MESACUP MODELS BP180 AND BP230 ELISA KITS

K071961 · Mbl International Corporation · Immunology
Aug 2008
Decision
406d
Days
Class 2
Risk

About This 510(k) Submission

K071961 is an FDA 510(k) clearance for the MESACUP MODELS BP180 AND BP230 ELISA KITS, a Autoantibodies, Skin (bullous Pemphigoid 180 And Bullous Pemphigoid 230 (Class II — Special Controls, product code OEG), submitted by Mbl International Corporation (Deer Field, US). The FDA issued a Cleared decision on August 25, 2008, 406 days after receiving the submission on July 16, 2007. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K071961 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 2007
Decision Date August 25, 2008
Days to Decision 406 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code OEG — Autoantibodies, Skin (bullous Pemphigoid 180 And Bullous Pemphigoid 230
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660
Definition The Device Is Intended As An Aid In The Diagnosis Of Bullous Pemphigoid.