Aalto Scientific, Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
35
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K163629Audit MicroControls Linearity FD Tumor Markers IIMarch 10, 2017
K161874Audit MicroControls Linearity DROP LQ Blood GlucoseAugust 10, 2016
K143571Audit MicroControls Linearity LQ Cystatin-CJanuary 23, 2015
K143573Audit MicroControls Linearity FD Tumor Markers IIJanuary 16, 2015
K143026Audit MicroControls Linearity FD Unsaturated Iron Binding CapacityNovember 21, 2014
K142978Audit MicroControls Linearity LQ Special DiabetesNovember 20, 2014
K130762AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SETApril 29, 2013
K130764AUDIT MICROCV VITAMIN D LINEARITY SETApril 26, 2013
K130157AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SETMarch 19, 2013
K112742AUDIT MICROLQ SPINAL FLUID CONTROLJune 15, 2012
K111964AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITYMarch 2, 2012
K112143AUDIT MICROCV T-UPTAKE LINEARITYJanuary 31, 2012
K112705AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROLJanuary 24, 2012
K100716AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5June 23, 2011
K103601AUDIT MICROCV IMMUNOASSAY LINEARITY SETJune 10, 2011
K101216AUDIT MICROCV PROTEIN LINEARITY SETJanuary 14, 2011
K102617AUDIT MICROCV CARDIAC MARKERS LINEARITY SETJanuary 10, 2011
K101427AUDIT MICROCV HS-CRP LINEARITY SETDecember 23, 2010
K100715AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5December 23, 2010
K100718AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5September 3, 2010