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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 the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Hematology, Inc.. It received FDA 510(k) clearance on 2018-03-02 under 510(k) 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. The listed applicant is Roche Diagnostics Hematology, Inc.. The 510(k) number is K171655.

When did cobas m 511 integrated hematology analyzer receive FDA 510(k) clearance?

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

Who is the listed applicant for cobas m 511 integrated hematology analyzer?

The FDA 510(k) record lists Roche Diagnostics Hematology, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: GKZ)

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.

K253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249Tru Hematology TestTruvian Sciences, Inc.K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, Inc.K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.K243283Alinity h-series SystemAbbott Laboratories

Official Source

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

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