IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST

System, Test, Anticardiolipin Immunological

GENERAL BIOMETRICS, INC.

The following data is part of a premarket notification filed by General Biometrics, Inc. with the FDA for Immunowell Cardiolipin Antibody (igg) Test.

Pre-market Notification Details

Device IDK920400
510k NumberK920400
Device Name:IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST
ClassificationSystem, Test, Anticardiolipin Immunological
Applicant GENERAL BIOMETRICS, INC. 15222 Avenue Of Science Suite A San Diego,  CA  92128
ContactBryan L Kiehl
CorrespondentBryan L Kiehl
GENERAL BIOMETRICS, INC. 15222 Avenue Of Science Suite A San Diego,  CA  92128
Product CodeMID  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-01-29
Decision Date1992-08-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613745030906 K920400 000

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