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FDA 510(k)

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

K-Number: K183205 · 2019-05-30

ApplicantEmcyte Corporation
Decision Date2019-05-30
Product CodeJQC
Advisory CommitteeCH
DecisionUnknown

Device Summary

PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System is the device name listed in this FDA 510(k) record. The listed applicant is Emcyte Corporation. It received FDA 510(k) clearance on 2019-05-30 under 510(k) number K183205. The device is classified under product code JQC. It was reviewed by the CH advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System?

PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System is a medical device that received FDA 510(k) clearance on 2019-05-30. The listed applicant is Emcyte Corporation. The 510(k) number is K183205.

When did PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System receive FDA 510(k) clearance?

PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System received FDA 510(k) clearance on 2019-05-30, under 510(k) number K183205.

Who is the listed applicant for PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System?

The FDA 510(k) record lists Emcyte Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System?

The FDA product code for PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System is JQC.

Related Clinical Trials

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NCT07491367Pilot Exploration of Platelet Characterization of Platelet Rich Plasma Created by Two Different SystemsRECRUITING

Other records listing Emcyte Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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