Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

cobas m 511 integrated hematology analyzer

K-Number: K171655 · 2018-03-02

ApplicantRoche Diagnostics Hematology, Inc.
Decision Date2018-03-02
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

cobas m 511 integrated hematology analyzer is a medical device manufactured by Roche Diagnostics Hematology, Inc.. It received FDA 510(k) clearance on 2018-03-02 under approval number K171655. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the cobas m 511 integrated hematology analyzer?

cobas m 511 integrated hematology analyzer is a medical device that received FDA 510(k) clearance on 2018-03-02. It is manufactured by Roche Diagnostics Hematology, Inc.. The 510(k) number is K171655.

When was cobas m 511 integrated hematology analyzer approved by the FDA?

cobas m 511 integrated hematology analyzer received FDA 510(k) clearance on 2018-03-02, under approval number K171655.

What company makes cobas m 511 integrated hematology analyzer?

cobas m 511 integrated hematology analyzer is manufactured by Roche Diagnostics Hematology, Inc..

What is the FDA product code for cobas m 511 integrated hematology analyzer?

The FDA product code for cobas m 511 integrated hematology analyzer is GKZ.

Related Clinical Trials

NCT06410755 Home-based Rehabilitation Monitoring System With Wearable Devices and Self-Report Application ACTIVE_NOT_RECRUITING

Related Devices (Code: GKZ)

K160538Sysmex XN-L Automated Hematology AnalyzerSysmex America, Inc. K162414UniCel DxH SlideMaker Stainer Coulter Cellular Analysis SystemBeckman Coulter, Inc. K160429BC-5390 Auto Hematology AnalyzerMindray Bio-Medical Electronics Co., Ltd. K172604XW-100 Automated Hematology Analyzer for CLIA Waived UseSysmex America, Inc. K170353ABX MICROS ES 60 OT and ABX MICROS ES 60 CTHORIBA ABX SAS K162977ADVIA 2120i, ADVIA 2120Siemens Healthcare Diagnostics

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.

↑