Cleared Traditional

AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL

K020618 · Aalto Scientific, Ltd. · Hematology
May 2002
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K020618 is an FDA 510(k) clearance for the AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL, a Control, Hematocrit (Class II — Special Controls, product code GLK), submitted by Aalto Scientific, Ltd. (Carlsbad, US). The FDA issued a Cleared decision on May 14, 2002, 78 days after receiving the submission on February 25, 2002. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K020618 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 2002
Decision Date May 14, 2002
Days to Decision 78 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GLK — Control, Hematocrit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625