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510(k) K951206

Device
VARELISA PARIETAL CELL ANTIBODIES
Applicant
ELIAS USA, INC.
510(k) number
K951206
Product code
MLE  
Decision
Substantially Equivalent (SESE)
Decision date
1995-04-17
Date received
1995-03-17
Regulation
866.5110
Classification name
Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
GOTTFRIED KELLERMANN
Address
373 280th St. Osceola WI US 54020 54020

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MLE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K010558QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISAInova Diagnostics, Inc.2001-04-03
K991942AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISACogent Diagnotics , Ltd.1999-08-24

Legacy Summary#

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FDA Review#

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