Cleared Traditional

hemochroma PLUS System

K182298 · Immunostics Inc., · Hematology
Nov 2018
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K182298 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., (Eatontown, US). The FDA issued a Cleared decision on November 16, 2018, 84 days after receiving the submission on August 24, 2018. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5620.

Submission Details

510(k) Number K182298 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 2018
Decision Date November 16, 2018
Days to Decision 84 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