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510(k) K193115

Device
EUROIMMUN Anti-BP230-CF ELISA (IgG)
Applicant
Euroimmun US, Inc.
510(k) number
K193115
Product code
OEG  
Decision
Substantially Equivalent (SESE)
Decision date
2020-09-17
Date received
2019-11-12
Regulation
866.5660
Classification name
Autoantibodies, Skin (bullous Pemphigoid 180 And Bullous Pemphigoid 230
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Kruti Shah
Address
1 Bloomfield Ave. Mountain Lakes NJ US 07046 07046

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code OEG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K083615EUROIMMUN ANTI BP 180-4X ELISA (IGG)Euroimmun Us, Inc.2009-03-16
K071961MESACUP MODELS BP180 AND BP230 ELISA KITSMbl International Corporation2008-08-25

Legacy Summary#

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FDA Review#

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