Aalto Scientific Ltd.

Eatonton, GA, US

AALTO SCIENTIFIC LTD. appears in FDA device records in Eatonton, GA. FDA records list 35 510(k) clearances between 1982-03-04 and 2017-03-10, no PMA records and one registered establishment. As of 2026-09-10, FDA records show no recalls for this company, and at least one establishment registration is current.

510(k) clearances: 35
PMA records: 0
Recall records: 0
Registered establishments: 1

510(k) clearance history

FDA records hold 35 510(k) clearances for Aalto Scientific Ltd. between 1982 and 2017. The busiest year on record is 2010, with 6. The most recent is 2017, with 1.

Clearances by year, as a table

510(k) clearance decisions for Aalto Scientific Ltd., by decision year
Year	Clearances
1982	1
1995	3
1996	1
2002	1
2003	1
2004	1
2006	1
2007	1
2008	2
2010	6
2011	4
2012	4
2013	3
2014	2
2015	2
2016	1
2017	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K163629	Audit MicroControls Linearity FD Tumor Markers II	JJY	Substantially Equivalent	2017-03-10
K161874	Audit MicroControls Linearity DROP LQ Blood Glucose	JJX	Substantially Equivalent	2016-08-10
K143571	Audit MicroControls Linearity LQ Cystatin-C	JJX	Substantially Equivalent	2015-01-23
K143573	Audit MicroControls Linearity FD Tumor Markers II	JJY	Substantially Equivalent	2015-01-16
K143026	Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity	JJX	Substantially Equivalent	2014-11-21
K142978	Audit MicroControls Linearity LQ Special Diabetes	JJY	Substantially Equivalent	2014-11-20
K130762	AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET	JJY	Substantially Equivalent	2013-04-29
K130764	AUDIT MICROCV VITAMIN D LINEARITY SET	JJX	Substantially Equivalent	2013-04-26
K130157	AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET	JJX	Substantially Equivalent	2013-03-19
K112742	AUDIT MICROLQ SPINAL FLUID CONTROL	JJY	Substantially Equivalent	2012-06-15
K111964	AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY	JJY	Substantially Equivalent	2012-03-02
K112143	AUDIT MICROCV T-UPTAKE LINEARITY	JJX	Substantially Equivalent	2012-01-31
K112705	AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL	JJY	Substantially Equivalent	2012-01-24
K100716	AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5	GGN	Substantially Equivalent	2011-06-23
K103601	AUDIT MICROCV IMMUNOASSAY LINEARITY SET	JJY	Substantially Equivalent	2011-06-10
K101216	AUDIT MICROCV PROTEIN LINEARITY SET	JJY	Substantially Equivalent	2011-01-14
K102617	AUDIT MICROCV CARDIAC MARKERS LINEARITY SET	JJY	Substantially Equivalent	2011-01-10
K101427	AUDIT MICROCV HS-CRP LINEARITY SET	JJX	Substantially Equivalent	2010-12-23
K100715	AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5	JJX	Substantially Equivalent	2010-12-23
K100718	AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5	JJY	Substantially Equivalent	2010-09-03
K101226	AUDIT MICROCV RF/CRP LINEARITY SET	JJY	Substantially Equivalent	2010-08-31
K101434	AUDIT MICROCV PROCALCITONIN LINEARITY	MJX	Substantially Equivalent	2010-07-22
K100750	AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-5	JJX	Substantially Equivalent	2010-05-21
K082714	AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5	JJY	Substantially Equivalent	2008-11-19
K082717	AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5	JJY	Substantially Equivalent	2008-10-30
K070223	AUDIT MICROCV LIPIDS LINEARITY SET (LOW)	JJY	Substantially Equivalent	2007-03-13
K062668	AUDIT MICROCV IMMUNOASSAY LINEARITY SET	JJY	Substantially Equivalent	2006-10-16
K042318	AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET	JJY	Substantially Equivalent	2004-12-09
K032122	AUDIT MICROCONTROLS MICROFD BNP CONTROL	JJY	Substantially Equivalent	2003-09-09
K020618	AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL	GLK	Substantially Equivalent	2002-05-14
K952126	AALTO SCIENTIFIC LIQUID CEREBROSPINAL FLUID CONTROLS LEVELS I AND II	GGP	Substantially Equivalent	1996-02-29
K954074	AALTO SCIENTIFIC LIQUID CARDIAC CONTROL	JJY	Substantially Equivalent	1995-10-07
K952720	AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II	JPK	Substantially Equivalent	1995-09-20
K951435	AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL	JJR	Substantially Equivalent	1995-05-02
K820360	AALTO LDH ISOENZYME CONTROL SERUM	JJT	Substantially Equivalent	1982-03-04

Registered establishments

FDA registered establishments for Aalto Scientific Ltd., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3011325031	3011325031	AALTO SCIENTIFIC LTD.	230 Technology Pkwy, Eatonton, GA 31024 US	2026	GGN GOD JJS JJT JJX JJY MJX

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain