FDA.reportPublic FDA data

510(k) K020757

Device
VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796
Applicant
Pharmacia Deutschland GmbH
510(k) number
K020757
Product code
MID
Decision
Substantially Equivalent (SESE)
Decision date
2002-05-02
Date received
2002-03-07
Regulation
866.5660
Classification name
System, Test, Anticardiolipin Immunological
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
MICHAEL LINSS
Address
Munzingerstrasse 7 Freiburg DE

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K032240BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KITThe Binding Site, Ltd.2003-09-29
K030741AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISAHycor Biomedical , Ltd.2003-05-01
K024196REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KITCorgenix, Inc.2003-01-03