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510(k) K193115

EUROIMMUN Anti-BP230-CF ELISA (IgG) by Euroimmun Us, Inc. — Product Code OEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2020
Date Received
November 12, 2019
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.

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Other clearances for product code OEG

  • K083615 — EUROIMMUN ANTI BP 180-4X ELISA (IGG) (March 16, 2009)
  • K071961 — MESACUP MODELS BP180 AND BP230 ELISA KITS (August 25, 2008)