Medical Device Manufacturer · US , Mchenry , IL

Aalto Scientific, Ltd. - FDA 510(k) Cleared Devices

35 submissions · 35 cleared · Since 1982

35

Total

35

Cleared

0

Denied

35 devices

26-35 of 35

Cleared Mar 13, 2007

AUDIT MICROCV LIPIDS LINEARITY SET (LOW)

Chemistry · 48d

Cleared Oct 16, 2006

AUDIT MICROCV IMMUNOASSAY LINEARITY SET

Chemistry · 38d

Cleared Dec 09, 2004

AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET

Chemistry · 105d

Cleared Sep 09, 2003

AUDIT MICROCONTROLS MICROFD BNP CONTROL

Chemistry · 62d

Cleared May 14, 2002

AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL

Hematology · 78d

Cleared Feb 29, 1996

AALTO SCIENTIFIC LIQUID CEREBROSPINAL FLUID CONTROLS LEVELS I AND II

Hematology · 297d

Cleared Oct 07, 1995

AALTO SCIENTIFIC LIQUID CARDIAC CONTROL

Chemistry · 38d

Cleared Sep 20, 1995

AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II

Hematology · 97d

Cleared May 02, 1995

AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL

Chemistry · 36d

Cleared Mar 04, 1982

AALTO LDH ISOENZYME CONTROL SERUM

Chemistry · 23d