ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY

Anti-rnp Antibody, Antigen And Control

ORGENTEC

The following data is part of a premarket notification filed by Orgentec with the FDA for Orgentec Anti-rnp/sm Pin Immuno Assay.

Pre-market Notification Details

Device IDK954831
510k NumberK954831
Device Name:ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY
ClassificationAnti-rnp Antibody, Antigen And Control
Applicant ORGENTEC P.O. BOX 451 Windham,  NH  03087
ContactRichard Conley
CorrespondentRichard Conley
ORGENTEC P.O. BOX 451 Windham,  NH  03087
Product CodeLKO  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-10-20
Decision Date1996-05-08

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