Audit MicroControls Linearity FD Tumor Markers II

Multi-analyte Controls, All Kinds (assayed)

AALTO SCIENTIFIC LTD.

The following data is part of a premarket notification filed by Aalto Scientific Ltd. with the FDA for Audit Microcontrols Linearity Fd Tumor Markers Ii.

Pre-market Notification Details

Device IDK143573
510k NumberK143573
Device Name:Audit MicroControls Linearity FD Tumor Markers II
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE. Carlsbad,  CA  92008
ContactRobert Burda
CorrespondentRobert Burda
AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE. Carlsbad,  CA  92008
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-17
Decision Date2015-01-16
Summary:summary

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