ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY

Anti-sm Antibody, Antigen And Control

ORGENTEC

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

Pre-market Notification Details

Device IDK954830
510k NumberK954830
Device Name:ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY
ClassificationAnti-sm 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 CodeLKP  
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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