REUMA TEST

System, Test, Rheumatoid Factor

SCLAVO, INC.

The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Reuma Test.

Pre-market Notification Details

Device IDK873782
510k NumberK873782
Device Name:REUMA TEST
ClassificationSystem, Test, Rheumatoid Factor
Applicant SCLAVO, INC. 5 MANSARD COURT Wayne,  NJ  07470
ContactDebra Hofmeister
CorrespondentDebra Hofmeister
SCLAVO, INC. 5 MANSARD COURT Wayne,  NJ  07470
Product CodeDHR  
CFR Regulation Number866.5775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-16
Decision Date1987-11-27

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