AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5

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 Microcv Tumor Markers Linearity Set, Model K719m-5.

Pre-market Notification Details

Device IDK082717
510k NumberK082717
Device Name:AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE. Carlsbad,  CA  92008
ContactBrandon J Perez
CorrespondentBrandon J Perez
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 Received2008-09-17
Decision Date2008-10-30
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.