IMMUNOWELL RNP/SM ANTIBODY TEST

Anti-sm Antibody, Antigen And Control

GENERAL BIOMETRICS, INC.

The following data is part of a premarket notification filed by General Biometrics, Inc. with the FDA for Immunowell Rnp/sm Antibody Test.

Pre-market Notification Details

Device IDK911848
510k NumberK911848
Device Name:IMMUNOWELL RNP/SM ANTIBODY TEST
ClassificationAnti-sm Antibody, Antigen And Control
Applicant GENERAL BIOMETRICS, INC. 15222 Avenue Of Science Suite A San Diego,  CA  92128
ContactBryan L.kiehl,phd.
CorrespondentBryan L.kiehl,phd.
GENERAL BIOMETRICS, INC. 15222 Avenue Of Science Suite A San Diego,  CA  92128
Product CodeLKP  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-04-26
Decision Date1991-05-07

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