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. Immunology ✕

5 devices

1-5 of 5

Cleared Mar 10, 2017

Audit MicroControls Linearity FD Tumor Markers II

Immunology · 78d

Cleared Jan 16, 2015

Audit MicroControls Linearity FD Tumor Markers II

Immunology · 30d

Cleared Jan 24, 2012

AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL

Immunology · 130d

Cleared Aug 31, 2010

AUDIT MICROCV RF/CRP LINEARITY SET

Immunology · 120d

Cleared Oct 30, 2008

AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5

Immunology · 43d