Is this your brand? Sign in to claim ownership.

Sign in to claim this brand

Aalto Scientific, Ltd.

United States·US-MF-000043518

Last updated June 8, 2026

Information

Country
United States
Address
230 Technology Parkway, Eatonton, United States
LinkedIn
—
Facebook
—
Phone
—
PRRC Contact
Robert Burda
EUDAMED SRN
US-MF-000043518
FDA FEI Number
—
DUNS Number
—

Catalogue (201)

Page 4 of 5
DeviceModel / ReferenceRegistriesClassStatus
Audit MicroControls Control FD Cardiac Markers K026M-6
FDA UDI
N/AActive
Audit MicroControls Linearity DROP LQ IL-6 K981M-5
FDA UDI
N/AActive
Audit MicroControls Control LQ Galectin-3 K895M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FLQ HbA1c for Bio-Rad Systems K983M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FLQ Anemia for Siemens Atellica/Centaur K819M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD iPTH Siemens Atellica K813M-5
FDA UDI
N/AActive
Audit MicroControls Linearity LQ Microalbumin / Microprotein K722M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD Lipids for Roche Systems K882M-5
FDA UDI
N/AActive
Audit MicroControls Control FD D-Dimer K072M-6
FDA UDI
N/AActive
Audit MicroControls Cal Ver LQ Blood Gas K727M-5
FDA UDI
N/AActive
Audit MicroControls Linearity LQ ASO K721M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD General Chemistry Panel 1 for Alfa Wassermann K864M-5
FDA UDI
N/AActive
Audit MicroControls Linearity FD Cardiac Markers Siemens Atellica K804M-5
FDA UDI
N/AActive
Audit MicroControls Control LQ Serum Protein K074M-6
FDA UDI
N/AActive
Audit MicroControls Linearity LQ Galectin-3 K760M-5
FDA UDI
N/AActive
Audit MicroControls Linearity LQ Protein K702M-5
FDA UDI
N/AActive
Audit Microcv Therapeutic Drug (tdm) Linearity Set K130762
FDA 510(k)
Class IActive
Audit Microcv D-Dimer Linearity Set, Model K717m-5 K100716
FDA 510(k)
Class IIActive
Audit Microcv T-Uptake Linearity K112143
FDA 510(k)
Class IActive
Audit Microcv Protein Linearity Set K101216
FDA 510(k)
Class IActive
Audit Microcv Aso Linearity Set, Model K721m-5 K100750
FDA 510(k)
Class IActive
Audit Microcv Rf/Crp Linearity Set K101226
FDA 510(k)
Class IActive
Aalto Scientific Ltd. Glycated Hemoglobin Control Levels I & Ii K952720
FDA 510(k)
Class IIActive
Audit MicroControls Linearity LQ Cystatin-C K143571
FDA 510(k)
Class IActive
Aalto Scientific Sweat Chloride Reference Material K951435
FDA 510(k)
Class IActive
Audit MicroControls Linearity FD Tumor Markers II K143573
FDA 510(k)
Class IActive
Aalto Ldh Isoenzyme Control Serum K820360
FDA 510(k)
Class IActive
Audit Microcv Urine/Fluids Chemistry Linearity K111964
FDA 510(k)
Class IActive
Audit Microcv Procalcitonin Linearity K101434
FDA 510(k)
Class IActive
Aalto Scientific Liquid Cardiac Control K954074
FDA 510(k)
Class IActive
Audit Microcv Lipids Linearity Set (low) K070223
FDA 510(k)
Class IActive
Audit Microcv Beta-Hydroxybutyric Acid Linearity Set K130157
FDA 510(k)
Class IActive
Audit(r) Microlq(tm) Serum Protein Control K112705
FDA 510(k)
Class IActive
Audit MicroControls Linearity FD Tumor Markers II K163629
FDA 510(k)
Class IActive
Audit Microcv Immunoassay Linearity Set K103601
FDA 510(k)
Class IActive
Audit Microcv Immunoassay Linearity Set K062668
FDA 510(k)
Class IActive
Audit Microcv Ammonian/Ethanol Linearity Set, Model K712m-5 K100718
FDA 510(k)
Class IActive
Audit Microcv Therapeutic Drug (tdm) Linearity Set, Model K707m-5 K082714
FDA 510(k)
Class IActive
Audit Microcv Tumor Markers Linearity Set, Model K719m-5 K082717
FDA 510(k)
Class IActive
Audit MicroControls Linearity DROP LQ Blood Glucose K161874
FDA 510(k)
Class IActive
Audit Microlq Spinal Fluid Control K112742
FDA 510(k)
Class IActive
Audit Microcv Cardiac Markers Linearity Set K102617
FDA 510(k)
Class IActive
Aalto Scientific Mirco Hematocrit Control K020618
FDA 510(k)
Class IIActive
Audit Microcv General Chemistry Linearity Set K042318
FDA 510(k)
Class IActive
Audit Microcv Homocysteine Linearity Set, Model 704m-5 K100715
FDA 510(k)
Class IActive
Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity K143026
FDA 510(k)
Class IActive
Audit MicroControls Linearity LQ Special Diabetes K142978
FDA 510(k)
Class IActive
Aalto Scientific Liquid Cerebrospinal Fluid Controls Levels I And Ii K952126
FDA 510(k)
Class IIActive
Audit Microcontrols Microfd Bnp Control K032122
FDA 510(k)
Class IActive
Audit Microcv Vitamin D Linearity Set K130764
FDA 510(k)
Class IActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.