Mesacup Models BP180 and BP230 Elisa Kits

FDA 510(k) K071961 · Mbl International Corporation

Substantially Equivalent

510(k) numberK071961

Submission

Device name
Mesacup Models BP180 and BP230 Elisa Kits
Applicant
Mbl International Corporation
Deer Field, IL, US
Received
July 16, 2007
Decision date
August 25, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OEG – Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5660
Specialty
Immunology

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

Other 510(k)s with product code OEG

510(k)DeviceApplicantDecision
K193115EUROIMMUN Anti-BP230-CF ELISA (IgG)OEG · Traditional Euroimmun Us, Inc.09/17/2020SE
K083615Euroimmun Anti BP 180-4X Elisa (Igg)OEG · Traditional Euroimmun Us, Inc.03/16/2009SE

More from Euroimmun Us, Inc.

510(k)DeviceDecision
K060431Anti RNA Polymerase III Elisa Kit, Model 7805NYO · Traditional 06/19/2006SE

Questions and answers

When was Mesacup Models BP180 and BP230 Elisa Kits cleared by the FDA?

Mesacup Models BP180 and BP230 Elisa Kits (K071961) received a 510(k) decision of Substantially Equivalent on August 25, 2008, 406 days after the submission was received.

What is the product code of K071961?

The FDA product code is OEG – Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230, a Class II (moderate risk) device regulated under 21 CFR 866.5660.