ELISA CMV IGM

Antibody Igm,if, Cytomegalovirus Virus

SCLAVO, INC.

The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Elisa Cmv Igm.

Pre-market Notification Details

Device IDK914789
510k NumberK914789
Device Name:ELISA CMV IGM
ClassificationAntibody Igm,if, Cytomegalovirus Virus
Applicant SCLAVO, INC. 5 MANSARD COURT Wayne,  NJ  07470
ContactMartin King
CorrespondentMartin King
SCLAVO, INC. 5 MANSARD COURT Wayne,  NJ  07470
Product CodeLKQ  
CFR Regulation Number866.3175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-10-23
Decision Date1992-03-04

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