ANTI NDNA IMMUNOFLOURESCENT TEST SYS

System, Test, Systemic Lupus Erythematosus

IMMUNO-PRODUCTS INDUSTRIES

The following data is part of a premarket notification filed by Immuno-products Industries with the FDA for Anti Ndna Immunoflourescent Test Sys.

Pre-market Notification Details

Device IDK810981
510k NumberK810981
Device Name:ANTI NDNA IMMUNOFLOURESCENT TEST SYS
ClassificationSystem, Test, Systemic Lupus Erythematosus
Applicant IMMUNO-PRODUCTS INDUSTRIES 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDHC  
CFR Regulation Number866.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-04-13
Decision Date1981-04-29

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