Cleared Traditional

HemoCue Hb 801 System

K181751 · Hemocue AB · Hematology
Feb 2019
Decision
214d
Days
Class 2
Risk

About This 510(k) Submission

K181751 is an FDA 510(k) clearance for the HemoCue Hb 801 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 February 1, 2019, 214 days after receiving the submission on July 2, 2018. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5620.

Submission Details

510(k) Number K181751 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2018
Decision Date February 01, 2019
Days to Decision 214 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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