Medical Device Manufacturer · US , Mchenry , IL

Aalto Scientific, Ltd. - FDA 510(k) Cleared Devices

35 submissions · 35 cleared · Since 1982

35

Total

35

Cleared

0

Denied

FDA 510(k) Regulatory Record - Aalto Scientific, Ltd. Chemistry ✕

24 devices

1-12 of 24

Cleared Aug 10, 2016

Audit MicroControls Linearity DROP LQ Blood Glucose

Chemistry · 33d

Cleared Jan 23, 2015

Audit MicroControls Linearity LQ Cystatin-C

Chemistry · 37d

Cleared Nov 21, 2014

Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity

Chemistry · 31d

Cleared Nov 20, 2014

Audit MicroControls Linearity LQ Special Diabetes

Chemistry · 36d

Cleared Apr 29, 2013

AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET

Chemistry · 40d

Cleared Apr 26, 2013

AUDIT MICROCV VITAMIN D LINEARITY SET

Chemistry · 37d

Cleared Mar 19, 2013

AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET

Chemistry · 55d

Cleared Jun 15, 2012

AUDIT MICROLQ SPINAL FLUID CONTROL

Chemistry · 268d

Cleared Mar 02, 2012

AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY

Chemistry · 235d

Cleared Jan 31, 2012

AUDIT MICROCV T-UPTAKE LINEARITY

Chemistry · 189d

Cleared Jun 10, 2011

AUDIT MICROCV IMMUNOASSAY LINEARITY SET

Chemistry · 184d

Cleared Jan 14, 2011

AUDIT MICROCV PROTEIN LINEARITY SET

Chemistry · 259d