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

FDA 510(k) Regulatory Record - Aalto Scientific, Ltd. Hematology ✕

4 devices

1-4 of 4

Cleared Jun 23, 2011

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

Hematology · 468d

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 Sep 20, 1995

AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II

Hematology · 97d