Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011325031

FEI Number

3011325031

Entity Name

AALTO SCIENTIFIC LTD.

City/State/Country

Eatonton, GA, US

Establishment Address

230 Technology Pkwy, Eatonton, GA 31024, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

AALTO SCIENTIFIC LTD. (Owner Number: 9000089)

Owner / Operator Contact Address

230 Technology Parkway, --, Eatonton, GA 31024, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Linearity FD D-Dimer for bioMerieux VIDAS Linearity FD D-Dimer PATHFAST Immunoanalyzer Linearity FD D-Dimer Control FD D-Dimer Linearity FD D-Dimer for Stago Systems Control FD Procalcitonin Linearity FD Procalcitonin for bioMerieux VIDAS Control FD G6PD for Baebies FINDER Control FD for bioMerieux VIDAS® NEPHROCLEAR CCL14 Linearity FD NT-proBNP for Abbott Systems Linearity LQ Osmolality Control LQ HbA1c Control FD HbA1c Linearity FD BNP Siemens Atellica Linearity FD HbA1c Glycohemoglobin A1c Controls Linearity FD Procalcitonin Linearity LQ Homocysteine Control LQ hs-CRP Linearity LQ Beta-Hydroxybutyric Acid Cal Ver LQ T-Uptake Tosoh AIA Linearity LQ hs-CRP Linearity FD General Chemistry Panel 2 for Ortho Vitros Linearity LQ ASO Linearity LQ Direct TIBC for Ortho Vitros Linearity FD UIBC Linearity FLQ Vitamin D for Ortho Vitros Linearity LQ Homocysteine Siemens Atellica Linearity FD iPTH for Ortho Vitros Linearity FD iPTH Siemens Atellica Linearity FD iPTH for Roche Systems Linearity FD iPTH for Abbott Systems Linearity LQ CRP for Ortho Vitros Linearity LQ Cystatin C Control FLQ Vitamin D Linearity FLQ Anti-Mullerian Hormone for Roche Systems Method Val FD GFAP for bioMerieux VIDAS® TBI (GFAP) Linearity FD Procalcitonin for Siemens Atellica Linearity FLQ Vitamin D Linearity FD Lipoprotein (a) Linearity FLQ Vitamin D for Roche Systems Linearity FLQ HbA1c Method Val FD UCH-L1 for bioMerieux VIDAS® TBI (UCH-L1) Control FD Traumatic Brain Injury (TBI) Linearity FD Lipids Beckman AU Linearity FD Cardiac Markers for Siemens Atellica Linearity FD General Chemistry Beckman AU Linearity FD Cardiac Markers Linearity FD TDM Linearity FD Fertility Siemens Atellica Linearity FD Lipids Linearity FD Anemia Siemens Atellica Control FD Urine Chemistry Linearity FD Urine/Fluids Chemistry Linearity FD Thyroid Siemens Atellica Linearity LQ Ammonia/Ethanol Linearity LQ Protein Control FD Immunoassay Linearity FD Tumor Markers for Siemens Atellica Linearity FD General Chemistry for Roche Systems Control FD BNP Control FD TDM Control FD Assayed Chemistry, Level 1 Control FD Assayed Chemistry, Level 2 Control LQ RF/CRP Linearity FD Bilirubin for Roche Systems Control FD Cardiac Markers Linearity FD Immunoassay Linearity FD Bilirubin Beckman AU Linearity FLQ Fertility for Roche Systems Linearity FD Lipids for Roche Systems Linearity FLQ Thyroids for Roche Systems Linearity LQ RF/CRP Linearity FD Immunoassay for Abbott Systems Linearity FD BNP (Extended) Linearity FD General Chemistry Linearity FD Thyroid for Abbott Systems Linearity FD Tumor Markers Linearity LQ Ammonia/Ethanol for Roche Systems Linearity FLQ Anemia for Roche Systems Linearity FLQ ISE + Trigs Linearity FD General Chemistry Panel 3 for Ortho Vitros Linearity FLQ TDM for Roche Systems Linearity FD General Chemistry Panel 4 for Ortho Vitros Linearity FD General Chemistry Panel 1 for Ortho Vitros Linearity FD General Chemistry Panel 3 for Abbott Systems Linearity FLQ Anemia for Siemens Atellica Linearity FD Cardiac Markers for PATHFAST Immunoanalyzer Linearity FLQ TDM for Ortho Vitros Linearity FD General Chemistry Panel 1 for Abbott Systems Linearity FD General Chemistry Panel 4 for Abbott Systems Linearity FD Cardiac Markers for Roche Systems Linearity FD General Chemistry Panel 2 for Abbott Systems Linearity FD Cardiac Markers for Ortho Vitros Linearity FLQ TDM for Beckman AU Linearity FLQ TDM for Abbott Systems Linearity FD Urine Chemistry Panel 1 for Abbott Systems Linearity FD Urine Chemistry Panel 2 for Abbott Systems Linearity FD General Chemistry Panel 2 for Alfa Wassermann Linearity FD Traumatic Brain Injury (TBI) Linearity LQ Special Proteins Linearity FD GFAP, UCH-L1 for bioMerieux VIDAS® TBI (GFAP, UCH-L1) Control FD GFAP, UCH-L1 for bioMerieux VIDAS® TBI (GFAP, UCH-L1) Linearity FD Tumor Markers for Roche Systems Linearity LQ Ammonia/Ethanol for Abbott Systems Linearity FD Bilirubin Linearity FD ISE for Siemens Atellica Linearity FLQ Fertility Siemens Atellica Linearity FD General Chemistry Panel 3 for Alfa Wassermann Linearity FD Urine Chemistry for Beckman AU Linearity FD Special Diabetes Linearity FD Thryoid for Ortho Vitros Linearity FD General Chemistry Panel 1 for Alfa Wassermann Linearity FD General Chemistry Panel 4 for Alfa Wassermann Linearity LQ Ammonia/Alcohol for Ortho Vitros Linearity FD Tumor Markers for Abbott Systems Linearity FLQ Special Diabetes for Roche Systems Cal Ver LQ Blood Gas

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2019-08-26
MJX	Kit, Serological, Positive Control	Clinical Chemistry	Class 1	862.1660	2019-08-08
JJT	Enzyme Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2021-06-07
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2017-05-09
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2017-05-09
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2019-08-08

Official Correspondent

Robert Burda

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AALTO SCIENTIFIC LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K021022	Instrumentation Laboratory CO	HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)	2002-05-14
K113211	Instrumentation Laboratory CO	HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL	2012-01-04
K082859	Instrumentation Laboratory CO	HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED	2008-12-19
K882795	Baxter Healthcare Corp	DADE(R) CK-MB IMMUNOASSAY CONTROL	1988-08-29
K971777	Instrumentation Laboratory CO	QUANTEX ASO-CRP-RF CONTROL	1997-05-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0514-2014	Instrumentation Laboratory Co.	2	HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
Z-0515-2014	Instrumentation Laboratory Co.	2	HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
Z-0516-2014	Instrumentation Laboratory Co.	2	HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011325031. Last updated year: 2026. Please use registration number 3011325031 when referencing this establishment in official correspondence.