Cleared Traditional

MEDICA EASYQC HEMATOCRIT CONTROL

K021924 · Bionostics, Inc. · Hematology
Jun 2002
Decision
13d
Days
Class 2
Risk

About This 510(k) Submission

K021924 is an FDA 510(k) clearance for the MEDICA EASYQC HEMATOCRIT CONTROL, a Control, Hematocrit (Class II — Special Controls, product code GLK), submitted by Bionostics, Inc. (Devens, US). The FDA issued a Cleared decision on June 24, 2002, 13 days after receiving the submission on June 11, 2002. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K021924 FDA.gov
FDA Decision Cleared SESE
Date Received June 11, 2002
Decision Date June 24, 2002
Days to Decision 13 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

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