Euroimmun Anti BP 180-4X Elisa (Igg)

FDA 510(k) K083615 · Euroimmun Us, Inc.

Substantially Equivalent

510(k) numberK083615

Submission

Device name
Euroimmun Anti BP 180-4X Elisa (Igg)
Applicant
Euroimmun Us, Inc.
Morristown, NJ, US
Received
December 8, 2008
Decision date
March 16, 2009
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
K193115EUROIMMUN Anti-BP230-CF ELISA (IgG)OEG · Traditional Euroimmun Us, Inc.09/17/2020SE
K071961Mesacup Models BP180 and BP230 Elisa KitsOEG · Traditional Mbl International Corporation08/25/2008SE

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Questions and answers

When was Euroimmun Anti BP 180-4X Elisa (Igg) cleared by the FDA?

Euroimmun Anti BP 180-4X Elisa (Igg) (K083615) received a 510(k) decision of Substantially Equivalent on March 16, 2009, 98 days after the submission was received.

What is the product code of K083615?

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.