Cleared Special

PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System

K183205 · Emcyte Corporation · Hematology
May 2019
Decision
192d
Days
Class 1
Risk

About This 510(k) Submission

K183205 is an FDA 510(k) clearance for the PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System, a Centrifuges (micro, Ultra, Refrigerated) For Clinical Use (Class I — General Controls, product code JQC), submitted by Emcyte Corporation (Fort Meyers, US). The FDA issued a Cleared decision on May 30, 2019, 192 days after receiving the submission on November 19, 2018. This device falls under the Hematology review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number K183205 FDA.gov
FDA Decision Cleared SESU
Date Received November 19, 2018
Decision Date May 30, 2019
Days to Decision 192 days
Submission Type Special
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code JQC — Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2050

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