Cleared Traditional

AnemoCheck

K163215 · Sanguina, LLC · Hematology

Sep 2017

Decision

301d

Days

Class 2

Risk

About This 510(k) Submission

K163215 is an FDA 510(k) clearance for the AnemoCheck, a Whole Blood Hemoglobin Determination (Class II — Special Controls, product code KHG), submitted by Sanguina, LLC (Atlanta, US). The FDA issued a Cleared decision on September 13, 2017, 301 days after receiving the submission on November 16, 2016. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7500.

Submission Details

510(k) Number	K163215 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 16, 2016
Decision Date	September 13, 2017
Days to Decision	301 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF