AUTOFLUOR V SYSTEM

Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

TECH AMERICA DIAGNOSTICS

The following data is part of a premarket notification filed by Tech America Diagnostics with the FDA for Autofluor V System.

Pre-market Notification Details

Device IDK842991
510k NumberK842991
Device Name:AUTOFLUOR V SYSTEM
ClassificationAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant TECH AMERICA DIAGNOSTICS 348-A RANCHEROS DR. San Marcos,  CA  92069
ContactJudith A Gawarecki
CorrespondentJudith A Gawarecki
TECH AMERICA DIAGNOSTICS 348-A RANCHEROS DR. San Marcos,  CA  92069
Product CodeDHN  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-07-30
Decision Date1985-03-14

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