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510(k) K071961

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

K071961 is an FDA 510(k) premarket notification submitted by Mbl International Corporation for the device "MESACUP MODELS BP180 AND BP230 ELISA KITS". The FDA issued a decision of Substantially Equivalent on August 25, 2008. The device falls under product code OEG (Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230), a Class II device regulated under 21 CFR 866.5660. Mbl International Corporation has at least 1 other 510(k) clearance on record.

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.

Other clearances by Mbl International Corporation

  • K060431 — ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805 (June 19, 2006)

Other clearances for product code OEG

  • K193115 — EUROIMMUN Anti-BP230-CF ELISA (IgG) (September 17, 2020)
  • K083615 — EUROIMMUN ANTI BP 180-4X ELISA (IGG) (March 16, 2009)

FDA data resources