EUROIMMUN Anti-BP230-CF ELISA (IgG)

FDA 510(k) K193115 · Euroimmun Us, Inc.

Substantially Equivalent

510(k) numberK193115

Submission

Device name
EUROIMMUN Anti-BP230-CF ELISA (IgG)
Applicant
Euroimmun Us, Inc.
Mountain Lakes, NJ, US
Received
November 12, 2019
Decision date
September 17, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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
K083615Euroimmun Anti BP 180-4X Elisa (Igg)OEG · Traditional Euroimmun Us, Inc.03/16/2009SE
K071961Mesacup Models BP180 and BP230 Elisa KitsOEG · Traditional Mbl International Corporation08/25/2008SE

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Questions and answers

When was EUROIMMUN Anti-BP230-CF ELISA (IgG) cleared by the FDA?

EUROIMMUN Anti-BP230-CF ELISA (IgG) (K193115) received a 510(k) decision of Substantially Equivalent on September 17, 2020, 310 days after the submission was received.

What is the product code of K193115?

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.