Aalto Scientific, Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Audit MicroControls Linearity FD Tumor Markers II, Audit MicroControls Linearity DROP LQ Blood Glucose, Audit MicroControls Linearity LQ Cystatin-C
35
Total
35
Cleared
0
Denied
FDA 510(k) Regulatory Record - Aalto Scientific, Ltd. Immunology ✕
5 devices
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