ELISA RUBELLA IGM

Enzyme Linked Immunoabsorbent Assay, Rubella

SCLAVO, INC.

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

Pre-market Notification Details

Device IDK914420
510k NumberK914420
Device Name:ELISA RUBELLA IGM
ClassificationEnzyme Linked Immunoabsorbent Assay, Rubella
Applicant SCLAVO, INC. 5 MANSARD COURT Wayne,  NJ  07470
ContactMartin King
CorrespondentMartin King
SCLAVO, INC. 5 MANSARD COURT Wayne,  NJ  07470
Product CodeLFX  
CFR Regulation Number866.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-10-03
Decision Date1991-12-27

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