ORGENTEC ENASCREEN PIN IMMUNO ASSAY

Extractable Antinuclear Antibody, Antigen And Control

ORGENTEC

The following data is part of a premarket notification filed by Orgentec with the FDA for Orgentec Enascreen Pin Immuno Assay.

Pre-market Notification Details

Device IDK955133
510k NumberK955133
Device Name:ORGENTEC ENASCREEN PIN IMMUNO ASSAY
ClassificationExtractable Antinuclear 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 CodeLLL  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-11-09
Decision Date1996-03-20

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