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510(k) K071961

Device
MESACUP MODELS BP180 AND BP230 ELISA KITS
Applicant
MBL INTERNATIONAL CORPORATION
510(k) number
K071961
Product code
OEG  
Decision
Substantially Equivalent (SESE)
Decision date
2008-08-25
Date received
2007-07-16
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
Summary
Third party reviewed
No

Applicant Contact#

Contact
DANIEL KAMM
Address
P.O. Box 7007 Deer Field IL US 60015 60015

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OEG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K193115EUROIMMUN Anti-BP230-CF ELISA (IgG)Euroimmun Us, Inc.2020-09-17
K083615EUROIMMUN ANTI BP 180-4X ELISA (IGG)Euroimmun Us, Inc.2009-03-16

Legacy Summary#

summary

FDA Review#

Decision Summary