Aalto Scientific L T D

FDA Filings

This page includes the latest FDA filings for Aalto Scientific L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3011325031
FEI Number3011325031
NameAALTO SCIENTIFIC LTD.
Owner & OperatorAALTO SCIENTIFIC LTD.
Contact Address230 Technology Parkway --
Eatonton GA 31024 US
Official Correspondent
  • Robert - Burda
  • x-760-4317922-134
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address230 Technology Pkwy
Eatonton, GA 31024 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device



FDA Filings

Device
Company
DeviceDate
AALTO SCIENTIFIC LTD.
Cal Ver FLQ Drugs of Abuse for Roche Systems2020-03-30
AALTO SCIENTIFIC LTD.
Linearity FD D-Dimer2019-08-26
AALTO SCIENTIFIC LTD.
Linearity FD D-Dimer bioMerieux VIDAS and miniVIDAS2019-08-26
AALTO SCIENTIFIC LTD.
Linearity FD D-Dimer Siemens Stratus2019-08-26
AALTO SCIENTIFIC LTD.
Linearity FD D-Dimer PATHFAST Immunoanalyzer2019-08-26
AALTO SCIENTIFIC LTD.
Control FD D-Dimer2019-08-26
AALTO SCIENTIFIC LTD.
MethodVal FD Procalcitonin bioMerieux VIDAS and miniVIDAS2019-08-08
AALTO SCIENTIFIC LTD.
Linearity FD Procalcitonin bioMerieux VIDAS and miniVIDAS2019-08-08
AALTO SCIENTIFIC LTD.
Control FD Procalcitonin2019-08-08
AALTO SCIENTIFIC LTD.
Cal Ver LQ Blood Gas2019-08-08
AALTO SCIENTIFIC LTD.
Linearity LQ RF/CRP2017-05-09
AALTO SCIENTIFIC LTD.
Linearity LQ Protein2017-05-09
AALTO SCIENTIFIC LTD.
Linearity LQ Microalbumin/Microprotein2017-05-09
AALTO SCIENTIFIC LTD.
Linearity LQ ISE2017-05-09
AALTO SCIENTIFIC LTD.
Linearity LQ Ammonia/Ethanol2017-05-09
AALTO SCIENTIFIC LTD.
Linearity LQ Ammonia/Ethanol for Roche Systems2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FLQ Thyroids for Roche Systems2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FLQ Special Diabetes for Siemens Centaur2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FLQ Special Diabetes for Roche Systems2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FLQ Fertility for Roche Systems2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FLQ Anemia for Roche Systems2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD Urine/Fluids Chemistry2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD Tumor Markers2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD Tumor Markers for Siemens Centaur2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD Thyroid for Siemens Centaur2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD Thyroid for Abbott Architect i Series2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD TDM2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD TDM Siemens Centaur2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD Special Diabetes for Ortho Vitros2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD Lipids2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD Lipids for Roche Systems2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD Lipids Beckman AU2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD Immunoassay2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD Immunoassay Abbott Architect i Series2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD HE4, HER2 Tumor Markers2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD General Chemistry2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD General Chemistry for Roche Systems2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD General Chemistry Panel 4 for Ortho Vitros2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD General Chemistry Panel 3 for Ortho Vitros2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD General Chemistry Panel 1 for Ortho Vitros2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD General Chemistry Beckman AU2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD Fertility Siemens Centaur2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD Cardiac for Siemens Stratus2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD Cardiac for RAMP2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD Cardiac Markers2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD Cardiac Markers Siemens Centaur2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD Bilirubin for Roche Systems2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD Bilirubin Beckman AU2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD BNP for RAMP2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD BNP (Low)2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD BNP (High)2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD BNP (Extended)2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD Anemia Siemens Centaur2017-05-09
AALTO SCIENTIFIC LTD.
Control LQ Serum Protein2017-05-09
AALTO SCIENTIFIC LTD.
Control LQ RF/CRP2017-05-09
AALTO SCIENTIFIC LTD.
Control LQ CSF2017-05-09
AALTO SCIENTIFIC LTD.
Control LQ Ammonia/Ethanol2017-05-09
AALTO SCIENTIFIC LTD.
Control FD Urine Chemistry2017-05-09
AALTO SCIENTIFIC LTD.
Control FD Tumor Markers2017-05-09
AALTO SCIENTIFIC LTD.
Control FD TDM2017-05-09
AALTO SCIENTIFIC LTD.
Control FD Immunoassay2017-05-09
AALTO SCIENTIFIC LTD.
Control FD HE4, HER2 Tumor Markers2017-05-09
AALTO SCIENTIFIC LTD.
Control FD Cardiac Markers2017-05-09
AALTO SCIENTIFIC LTD.
Control FD BNP2017-05-09
AALTO SCIENTIFIC LTD.
Control FD Assayed Chemistry, Level 22017-05-09
AALTO SCIENTIFIC LTD.
Control FD Assayed Chemistry, Level 12017-05-09
AALTO SCIENTIFIC LTD.
Linearity LQ hs-CRP2017-05-09
AALTO SCIENTIFIC LTD.
Linearity LQ Vitamin D2017-05-09
AALTO SCIENTIFIC LTD.
Linearity LQ Vitamin D Roche Systems2017-05-09
AALTO SCIENTIFIC LTD.
Linearity LQ Homocysteine2017-05-09
AALTO SCIENTIFIC LTD.
Linearity LQ Homocysteine Siemens Centaur2017-05-09
AALTO SCIENTIFIC LTD.
Linearity LQ Galectin-32017-05-09
AALTO SCIENTIFIC LTD.
Linearity LQ Beta-Hydroxybutyric Acid2017-05-09
AALTO SCIENTIFIC LTD.
Linearity LQ ASO2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FLQ Vitamin D for Ortho Vitros2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FLQ HbA1c for Abbott Systems2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD UIBC2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD Procalcitonin for Roche Systems2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD Procalcitonin Abbott Architect i Series2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD Glycohemoglobin A1c2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD General Chemistry Panel 2 for Ortho Vitros2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD BNP Siemens Stratus2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD BNP Siemens Centaur2017-05-09
AALTO SCIENTIFIC LTD.
Linearity FD BNP RAMP2017-05-09
AALTO SCIENTIFIC LTD.
Linearity DROP LQ TIBC for Ortho Vitros2017-05-09
AALTO SCIENTIFIC LTD.
Linearity DROP LQ Fructosamine for Roche Systems2017-05-09
AALTO SCIENTIFIC LTD.
Linearity DROP LQ Blood Glucose2017-05-09
AALTO SCIENTIFIC LTD.
Glycohemoglobin A1c Controls2017-05-09
AALTO SCIENTIFIC LTD.
Control LQ hs-CRP2017-05-09
AALTO SCIENTIFIC LTD.
Control LQ Vitamin D2017-05-09
AALTO SCIENTIFIC LTD.
Control LQ Vitamin D for Roche Systems2017-05-09
AALTO SCIENTIFIC LTD.
Control LQ Homocysteine2017-05-09
AALTO SCIENTIFIC LTD.
Control LQ Glycohemoglobin A1c2017-05-09
AALTO SCIENTIFIC LTD.
Control LQ Galectin-32017-05-09
AALTO SCIENTIFIC LTD.
Control FD Glycohemoglobin A1c2017-05-09
AALTO SCIENTIFIC LTD.
Control DROP LQ Blood Glucose2017-05-09
AALTO SCIENTIFIC LTD.
Cal Ver LQ T-Uptake Tosoh AIA2017-05-09
Aalto Scientific, Ltd.
Audit MicroControls Linearity FD Tumor Markers II2017-03-10
AALTO SCIENTIFIC LTD.
Control DROP LQ Urine Dipstick2017-01-20
AALTO SCIENTIFIC, LTD.
Audit MicroControls Linearity DROP LQ Blood Glucose2016-08-10
AALTO SCIENTIFIC, LTD.
Audit MicroControls Linearity LQ Cystatin-C2015-01-23
AALTO SCIENTIFIC LTD.
Audit MicroControls Linearity FD Tumor Markers II2015-01-16
AALTO SCIENTIFIC LTD.
Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity2014-11-21
AALTO SCIENTIFIC LTD.
Audit MicroControls Linearity LQ Special Diabetes2014-11-20
AALTO SCIENTIFIC LTD.
AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET2013-04-29
AALTO SCIENTIFIC LTD.
AUDIT MICROCV VITAMIN D LINEARITY SET2013-04-26
AALTO SCIENTIFIC LTD.
AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET2013-03-19
AALTO SCIENTIFIC LTD.
AUDIT MICROLQ SPINAL FLUID CONTROL2012-06-15
AALTO SCIENTIFIC LTD.
AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY2012-03-02
AALTO SCIENTIFIC LTD.
AUDIT MICROCV T-UPTAKE LINEARITY2012-01-31
AALTO SCIENTIFIC LTD.
AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL2012-01-24
AALTO SCIENTIFIC LTD.
AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-52011-06-23
AALTO SCIENTIFIC LTD.
AUDIT MICROCV IMMUNOASSAY LINEARITY SET2011-06-10
AALTO SCIENTIFIC LTD.
AUDIT MICROCV PROTEIN LINEARITY SET2011-01-14
AALTO SCIENTIFIC LTD.
AUDIT MICROCV CARDIAC MARKERS LINEARITY SET2011-01-10
AALTO SCIENTIFIC LTD.
AUDIT MICROCV HS-CRP LINEARITY SET2010-12-23
AALTO SCIENTIFIC LTD.
AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-52010-12-23
AALTO SCIENTIFIC LTD.
AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-52010-09-03
AALTO SCIENTIFIC LTD.
AUDIT MICROCV RF/CRP LINEARITY SET2010-08-31
AALTO SCIENTIFIC LTD.
AUDIT MICROCV PROCALCITONIN LINEARITY2010-07-22
AALTO SCIENTIFIC LTD.
AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-52010-05-21
AALTO SCIENTIFIC LTD.
AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-52008-10-30
AALTO SCIENTIFIC LTD.
AUDIT MICROCV LIPIDS LINEARITY SET (LOW)2007-03-13
AALTO SCIENTIFIC LTD.
AUDIT MICROCV IMMUNOASSAY LINEARITY SET2006-10-16
AALTO SCIENTIFIC LTD.
AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET2004-12-09
AALTO SCIENTIFIC LTD.
AALTO SCIENTIFIC LIQUID CEREBROSPINAL FLUID CONTROLS LEVELS I AND II1996-02-29
AALTO SCIENTIFIC LTD.
AALTO SCIENTIFIC LIQUID CARDIAC CONTROL1995-10-07
AALTO SCIENTIFIC LTD.
AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II1995-09-20
AALTO SCIENTIFIC LTD.
AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL1995-05-02
AALTO SCIENTIFIC LTD.
AALTO LDH ISOENZYME CONTROL SERUM1982-03-04

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