Medical Device Manufacturer · US , Mchenry , IL

Aalto Scientific, Ltd.

35 submissions · 35 cleared · Since 1982
35
Total
35
Cleared
0
Denied

Aalto Scientific, Ltd. — FDA 510(k) Submissions

Aalto Scientific, Ltd. has submitted 35 FDA 510(k) premarket notifications since 1982, of which 35 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Multi-analyte Controls, All Kinds (assayed), Single (specified) Analyte Controls (assayed And Unassayed), Plasma, Coagulation Control, Kit, Serological, Positive Control, Enzyme Controls (assayed And Unassayed) . Use the specialty filter in the sidebar to narrow results.

35 devices
1–25 of 35
Audit MicroControls Linearity FD Tumor Markers II
K163629 · JJY Multi-analyte Controls,... · Immunology
Mar 2017 78d
Audit MicroControls Linearity DROP LQ Blood Glucose
K161874 · JJX Single (specified)... · Chemistry
Aug 2016 33d
Audit MicroControls Linearity LQ Cystatin-C
K143571 · JJX Single (specified)... · Chemistry
Jan 2015 37d
Audit MicroControls Linearity FD Tumor Markers II
K143573 · JJY Multi-analyte Controls,... · Immunology
Jan 2015 30d
Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity
K143026 · JJX Single (specified)... · Chemistry
Nov 2014 31d
Audit MicroControls Linearity LQ Special Diabetes
K142978 · JJY Multi-analyte Controls,... · Chemistry
Nov 2014 36d
AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET
K130762 · JJY Multi-analyte Controls,... · Chemistry
Apr 2013 40d
AUDIT MICROCV VITAMIN D LINEARITY SET
K130764 · JJX Single (specified)... · Chemistry
Apr 2013 37d
AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET
K130157 · JJX Single (specified)... · Chemistry
Mar 2013 55d
AUDIT MICROLQ SPINAL FLUID CONTROL
K112742 · JJY Multi-analyte Controls,... · Chemistry
Jun 2012 268d
AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY
K111964 · JJY Multi-analyte Controls,... · Chemistry
Mar 2012 235d
AUDIT MICROCV T-UPTAKE LINEARITY
K112143 · JJX Single (specified)... · Chemistry
Jan 2012 189d
AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL
K112705 · JJY Multi-analyte Controls,... · Immunology
Jan 2012 130d
AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5
K100716 · GGN Plasma, Coagulation Control · Hematology
Jun 2011 468d
AUDIT MICROCV IMMUNOASSAY LINEARITY SET
K103601 · JJY Multi-analyte Controls,... · Chemistry
Jun 2011 184d
AUDIT MICROCV PROTEIN LINEARITY SET
K101216 · JJY Multi-analyte Controls,... · Chemistry
Jan 2011 259d
AUDIT MICROCV CARDIAC MARKERS LINEARITY SET
K102617 · JJY Multi-analyte Controls,... · Chemistry
Jan 2011 122d
AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5
K100715 · JJX Single (specified)... · Chemistry
Dec 2010 286d
AUDIT MICROCV HS-CRP LINEARITY SET
K101427 · JJX Single (specified)... · Chemistry
Dec 2010 216d
AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5
K100718 · JJY Multi-analyte Controls,... · Chemistry
Sep 2010 175d
AUDIT MICROCV RF/CRP LINEARITY SET
K101226 · JJY Multi-analyte Controls,... · Immunology
Aug 2010 120d
AUDIT MICROCV PROCALCITONIN LINEARITY
K101434 · MJX Kit, Serological,... · Microbiology
Jul 2010 62d
AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-5
K100750 · JJX Single (specified)... · Microbiology
May 2010 66d
AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5
K082714 · JJY Multi-analyte Controls,... · Chemistry
Nov 2008 63d
AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5
K082717 · JJY Multi-analyte Controls,... · Immunology
Oct 2008 43d
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