ANTI-DS/N-DNA TEST KIT

Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

IMMUNO-DIAGNOSTIC PRODUCTS, INC.

The following data is part of a premarket notification filed by Immuno-diagnostic Products, Inc. with the FDA for Anti-ds/n-dna Test Kit.

Pre-market Notification Details

Device IDK801960
510k NumberK801960
Device Name:ANTI-DS/N-DNA TEST KIT
ClassificationMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Applicant IMMUNO-DIAGNOSTIC PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDBL  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-08-19
Decision Date1980-10-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.