AALTO SCIENTIFIC LTD.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3011325031	3011325031	AALTO SCIENTIFIC LTD.	1	N	2026-01-01	230 Technology Pkwy Eatonton GA US 31024

Registered Device Listings#

Registration key, Listing key table
Registration key	Listing key
182117	1055450593
182117	1164009692
182117	1008403296
182117	1012935555
182117	1376745745
182117	1393682943
182117	1803998140
182117	1918291202
182117	2061194490

PMN#

Audit MicroControls Linearity FD Tumor Markers II

2017-03-10

Aalto Scientific, Ltd.

Audit MicroControls Linearity DROP LQ Blood Glucose

2016-08-10

AALTO SCIENTIFIC, LTD.

Audit MicroControls Linearity LQ Cystatin-C

2015-01-23

AALTO SCIENTIFIC, LTD.

Audit MicroControls Linearity FD Tumor Markers II

2015-01-16

AALTO SCIENTIFIC LTD.

Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity

2014-11-21

AALTO SCIENTIFIC LTD.

Audit MicroControls Linearity LQ Special Diabetes

2014-11-20

AALTO SCIENTIFIC LTD.

AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET

2013-04-29

AALTO SCIENTIFIC LTD.

AUDIT MICROCV VITAMIN D LINEARITY SET

2013-04-26

AALTO SCIENTIFIC LTD.

AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET

2013-03-19

AALTO SCIENTIFIC LTD.

AUDIT MICROLQ SPINAL FLUID CONTROL

2012-06-15

AALTO SCIENTIFIC LTD.

AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY

2012-03-02

AALTO SCIENTIFIC LTD.

AUDIT MICROCV T-UPTAKE LINEARITY

2012-01-31

AALTO SCIENTIFIC LTD.

AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL

2012-01-24

AALTO SCIENTIFIC LTD.

AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5

2011-06-23

AALTO SCIENTIFIC LTD.

AUDIT MICROCV IMMUNOASSAY LINEARITY SET

2011-06-10

AALTO SCIENTIFIC LTD.

AUDIT MICROCV PROTEIN LINEARITY SET

2011-01-14

AALTO SCIENTIFIC LTD.

AUDIT MICROCV CARDIAC MARKERS LINEARITY SET

2011-01-10

AALTO SCIENTIFIC LTD.

AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5

2010-12-23

AALTO SCIENTIFIC LTD.

AUDIT MICROCV HS-CRP LINEARITY SET

2010-12-23

AALTO SCIENTIFIC LTD.

AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5

2010-09-03

AALTO SCIENTIFIC LTD.

AUDIT MICROCV RF/CRP LINEARITY SET

2010-08-31

AALTO SCIENTIFIC LTD.

AUDIT MICROCV PROCALCITONIN LINEARITY

2010-07-22

AALTO SCIENTIFIC LTD.

AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-5

2010-05-21

AALTO SCIENTIFIC LTD.

AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5

2008-11-19

Aalto Scientific, Ltd.

AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5

2008-10-30

AALTO SCIENTIFIC LTD.

AUDIT MICROCV LIPIDS LINEARITY SET (LOW)

2007-03-13

AALTO SCIENTIFIC LTD.

AUDIT MICROCV IMMUNOASSAY LINEARITY SET

2006-10-16

AALTO SCIENTIFIC LTD.

AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET

2004-12-09

AALTO SCIENTIFIC LTD.

AALTO SCIENTIFIC LIQUID CEREBROSPINAL FLUID CONTROLS LEVELS I AND II

1996-02-29

AALTO SCIENTIFIC LTD.

AALTO SCIENTIFIC LIQUID CARDIAC CONTROL

1995-10-07

AALTO SCIENTIFIC LTD.

AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II

1995-09-20

AALTO SCIENTIFIC LTD.

AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL

1995-05-02

AALTO SCIENTIFIC LTD.

AALTO LDH ISOENZYME CONTROL SERUM

1982-03-04

AALTO SCIENTIFIC LTD.

GUDID#

Audit MicroControls Linearity FD Tumor Markers for Roche Systems - K924M-10

AALTO SCIENTIFIC

2025-12-18

Audit MicroControls Control LQ COVID-19 IgG + IgM Antibodies - K087M-6

AALTO SCIENTIFIC

2020-11-12

Audit MicroControls Linearity FLQ Troponin T for Roche Systems - K932M-5

AALTO SCIENTIFIC

2020-11-03

Audit MicroControls Linearity FD ISE for Siemens Atellica - K815M-5

AALTO SCIENTIFIC

2025-11-26

Audit MicroControls Linearity FD Tumor Markers for Abbott Systems - K939M-10

AALTO SCIENTIFIC

2025-11-26

Audit MicroControls Linearity FD Lipoprotein (a) - K743M-5

AALTO SCIENTIFIC

2025-11-20

Audit MicroControls Linearity FD Urine Chemistry for Beckman AU - K829M-10

AALTO SCIENTIFIC

2025-11-20

Audit MicroControls Linearity FLQ Special Diabetes for Roche Systems - K922M-5

AALTO SCIENTIFIC

2024-12-16

Audit MicroControls Linearity FD BNP for Abbott Systems - K836M-5

AALTO SCIENTIFIC

2025-07-22

Audit MicroControls Linearity LQ Ammonia/Alcohol for Ortho Vitros - K830M-5

AALTO SCIENTIFIC

2025-07-10

Audit MicroControls Linearity LQ Special Proteins - K762M-5

AALTO SCIENTIFIC

2025-04-28

Audit MicroControls Linearity FD Traumatic Brain Injury (TBI) - K739M-10

AALTO SCIENTIFIC

2025-04-10

Audit MicroControls Linearity FD Bilirubin - K742M-5

AALTO SCIENTIFIC

2025-04-10

Audit MicroControls Linearity FD General Chemistry Panel 1 for Alfa Wassermann - K864M-5

AALTO SCIENTIFIC

2025-03-06

Audit MicroControls Linearity FD General Chemistry Panel 2 for Alfa Wassermann - K865M-5

AALTO SCIENTIFIC

2025-03-06

Audit MicroControls Linearity FD General Chemistry Panel 3 for Alfa Wassermann - K866M-5

AALTO SCIENTIFIC

2025-03-06

Audit MicroControls Linearity FD General Chemistry Panel 4 for Alfa Wassermann - K867M-10

AALTO SCIENTIFIC

2025-03-06

Audit MicroControls Control FD HbA1c - K061M-6

AALTO SCIENTIFIC

2018-03-27

Audit MicroControls Method Val FD UCH-L1 for bioMérieux VIDAS® TBI (UCH-L1) - K852M-20

AALTO SCIENTIFIC

2025-01-06

Audit MicroControls Linearity FD GFAP, UCH-L1 for bioMérieux VIDAS® TBI (GFAP, U - Note - Max characters were exceeded for Brand Name field. Brand name is "Audit MicroControls Linearity FD GFAP, UCH-L1 for bioMérieux VIDAS® TBI (GFAP, UCH-L1)".

AALTO SCIENTIFIC

2024-12-06

Audit MicroControls Control FD GFAP, UCH-L1 for bioMérieux VIDAS® TBI (GFAP, UCH - Note - Max characters were exceeded for Brand Name field. Brand name is "Audit MicroControls Control FD GFAP, UCH-L1 for bioMérieux VIDAS® TBI (GFAP, UCH-L1)".

AALTO SCIENTIFIC

2024-12-06

Audit MicroControls Linearity FD GFAP, UCH-L1 for bioMérieux VIDAS® TBI (GFAP, U - Note - Max characters were exceeded for Brand Name field. Brand name is "Audit MicroControls Linearity FD GFAP, UCH-L1 for bioMérieux VIDAS® TBI (GFAP, UCH-L1)".

AALTO SCIENTIFIC

2024-12-06

Audit MicroControls Method Val FD GFAP for bioMérieux VIDAS® TBI (GFAP) - K853M-20

AALTO SCIENTIFIC

2024-12-06

Audit MicroControls Linearity FLQ Vitamin D - K764M-5

AALTO SCIENTIFIC

2024-11-20

Audit MicroControls Control FLQ Vitamin D - K082M-10

AALTO SCIENTIFIC

2024-07-03

Audit MicroControls Linearity FLQ Vitamin D for Roche Systems - K923M-5

AALTO SCIENTIFIC

2024-05-16

Audit MicroControls Linearity FD Urine Chemistry Panel 1 - K897M-5

AALTO SCIENTIFIC

2024-04-09

Audit MicroControls Linearity FD Urine Chemistry Panel 2 - K898M-5

AALTO SCIENTIFIC

2024-04-09

Audit MicroControls Linearity FD Special Diabetes - K889M-5

AALTO SCIENTIFIC

2023-12-18

Audit MicroControls Linearity FLQ Fertility Siemens Atellica/Centaur - K818M-5

AALTO SCIENTIFIC

2023-06-15

Audit MicroControls Linearity FLQ Cardiac Markers for Ortho Vitros - K908M-5

AALTO SCIENTIFIC

2023-06-15

Audit MicroControls Linearity FLQ Cardiac Markers for Roche Systems - K936M-5

AALTO SCIENTIFIC

2023-06-15

Audit MicroControls Linearity FLQ General Chemistry Panel 3 for Roche Systems - K919M-5

AALTO SCIENTIFIC

2023-06-06

Audit MicroControls Linearity FD D-Dimer for Stago Systems - K958M-5

AALTO SCIENTIFIC

2023-06-06

Audit MicroControls Linearity FLQ Thyroids for Roche Systems - K926M-5

AALTO SCIENTIFIC

2019-07-23

Audit MicroControls Linearity FLQ Anti-Mullerian Hormone for Roche Systems - K896M-5

AALTO SCIENTIFIC

2022-11-16

Audit MicroControls Linearity LQ hsCRP for Ortho Vitros - K907M-5

AALTO SCIENTIFIC

2022-08-30

Audit MicroControls Linearity FD Bilirubin Supplement - K701M-SUPP

AALTO SCIENTIFIC

2022-07-12

Audit MicroControls Linearity FLQ HbA1c for Bio-Rad Systems - K983M-5

AALTO SCIENTIFIC

2022-03-08

Audit MicroControls Linearity FLQ General Chemistry Panel 2 for Roche Systems - K918M-5

AALTO SCIENTIFIC

2022-03-02

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