RF-II TEST KIT

System, Test, Rheumatoid Factor

IMMUNO-DIAGNOSTIC PRODUCTS, INC.

The following data is part of a premarket notification filed by Immuno-diagnostic Products, Inc. with the FDA for Rf-ii Test Kit.

Pre-market Notification Details

Device IDK801961
510k NumberK801961
Device Name:RF-II TEST KIT
ClassificationSystem, Test, Rheumatoid Factor
Applicant IMMUNO-DIAGNOSTIC PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDHR  
CFR Regulation Number866.5775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-08-19
Decision Date1980-10-10

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