AUDIT MICROCV VITAMIN D LINEARITY SET

Single (specified) Analyte Controls (assayed And Unassayed)

AALTO SCIENTIFIC LTD.

The following data is part of a premarket notification filed by Aalto Scientific Ltd. with the FDA for Audit Microcv Vitamin D Linearity Set.

Pre-market Notification Details

Device IDK130764
510k NumberK130764
Device Name:AUDIT MICROCV VITAMIN D LINEARITY SET
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE. Carlsbad,  CA  92008
ContactDessi Lyakov
CorrespondentDessi Lyakov
AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE. Carlsbad,  CA  92008
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-03-20
Decision Date2013-04-26
Summary:summary

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