Cleared Traditional

hemochroma PLUS System

K163465 · Immunostics Inc., · Hematology
Sep 2017
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K163465 is an FDA 510(k) clearance for the hemochroma PLUS System, a System, Hemoglobin, Automated (Class II — Special Controls, product code GKR), submitted by Immunostics Inc., (Ocean, US). The FDA issued a Cleared decision on September 8, 2017, 270 days after receiving the submission on December 12, 2016. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5620.

Submission Details

510(k) Number K163465 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 2016
Decision Date September 08, 2017
Days to Decision 270 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