Aalto Scientific, Ltd. - FDA 510(k) Cleared Devices
35
Total
35
Cleared
0
Denied
FDA 510(k) Regulatory Record - Aalto Scientific, Ltd. Chemistry ✕
24 devices
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
Cleared
Jan 10, 2011
AUDIT MICROCV CARDIAC MARKERS LINEARITY SET
Chemistry
122d
Cleared
Dec 23, 2010
AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5
Chemistry
286d
Cleared
Dec 23, 2010
AUDIT MICROCV HS-CRP LINEARITY SET
Chemistry
216d
Cleared
Sep 03, 2010
AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5
Chemistry
175d
Cleared
Nov 19, 2008
AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5
Chemistry
63d
Cleared
Mar 13, 2007
AUDIT MICROCV LIPIDS LINEARITY SET (LOW)
Chemistry
48d
Cleared
Oct 16, 2006
AUDIT MICROCV IMMUNOASSAY LINEARITY SET
Chemistry
38d
Cleared
Dec 09, 2004
AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET
Chemistry
105d
Cleared
Sep 09, 2003
AUDIT MICROCONTROLS MICROFD BNP CONTROL
Chemistry
62d
Cleared
Oct 07, 1995
AALTO SCIENTIFIC LIQUID CARDIAC CONTROL
Chemistry
38d
Cleared
May 02, 1995
AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL
Chemistry
36d
Cleared
Mar 04, 1982
AALTO LDH ISOENZYME CONTROL SERUM
Chemistry
23d