IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL

Extractable Antinuclear 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 Immunodot(r) Ena/dna Autoimmunity Screening Panel.

Pre-market Notification Details

Device IDK924843
510k NumberK924843
Device Name:IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL
ClassificationExtractable Antinuclear Antibody, Antigen And Control
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 CodeLLL  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-09-28
Decision Date1992-12-01

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