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FDA 510(k)

Sysmex Automated Blood Coagulation Analyzer CS-5100

K-Number: K162420 · 2016-12-12

ApplicantSiemens Healthcare Diagnostics Products GmbH
Decision Date2016-12-12
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Sysmex Automated Blood Coagulation Analyzer CS-5100 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. It received FDA 510(k) clearance on 2016-12-12 under 510(k) number K162420. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sysmex Automated Blood Coagulation Analyzer CS-5100?

Sysmex Automated Blood Coagulation Analyzer CS-5100 is a medical device that received FDA 510(k) clearance on 2016-12-12. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K162420.

When did Sysmex Automated Blood Coagulation Analyzer CS-5100 receive FDA 510(k) clearance?

Sysmex Automated Blood Coagulation Analyzer CS-5100 received FDA 510(k) clearance on 2016-12-12, under 510(k) number K162420.

Who is the listed applicant for Sysmex Automated Blood Coagulation Analyzer CS-5100?

The FDA 510(k) record lists Siemens Healthcare Diagnostics Products GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sysmex Automated Blood Coagulation Analyzer CS-5100?

The FDA product code for Sysmex Automated Blood Coagulation Analyzer CS-5100 is JPA.

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Related Devices (Code: JPA)

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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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