Cleared Traditional

HemoCue Hb 301 System

K201217 · Hemocue AB · Hematology
Aug 2020
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K201217 is an FDA 510(k) clearance for the HemoCue Hb 301 System, a System, Hemoglobin, Automated (Class II — Special Controls, product code GKR), submitted by Hemocue AB (?ngelholm, SE). The FDA issued a Cleared decision on August 4, 2020, 90 days after receiving the submission on May 6, 2020. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5620.

Submission Details

510(k) Number K201217 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2020
Decision Date August 04, 2020
Days to Decision 90 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKR — System, Hemoglobin, Automated
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5620

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