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FDA 510(k)

Sysmex Automated Blood Coagulation Analyzer CS-5100

K-Number: K150678 · 2016-01-11

ApplicantSiemens Healthcare Diagnostic Products GmbH
Decision Date2016-01-11
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Sysmex Automated Blood Coagulation Analyzer CS-5100 is a medical device manufactured by Siemens Healthcare Diagnostic Products GmbH. It received FDA 510(k) clearance on 2016-01-11 under approval number K150678. 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 2016-01-11. It is manufactured by Siemens Healthcare Diagnostic Products GmbH. The 510(k) number is K150678.

When was Sysmex Automated Blood Coagulation Analyzer CS-5100 approved by the FDA?

Sysmex Automated Blood Coagulation Analyzer CS-5100 received FDA 510(k) clearance on 2016-01-11, under approval number K150678.

What company makes Sysmex Automated Blood Coagulation Analyzer CS-5100?

Sysmex Automated Blood Coagulation Analyzer CS-5100 is manufactured by Siemens Healthcare Diagnostic Products GmbH.

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 PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025)

Other Devices by Siemens Healthcare Diagnostic Products GmbH

K172286Automated Blood Coagulation Analyzer CS-2500 K232624CardioPhase® hsCRP K242952INNOVANCE Antithrombin

Related Devices (Code: JPA)

K162688Sysmex CS-2100iSiemens Healthcare Diagnostics Products GmbH K162420Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostics Products GmbH K161317Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostics Products GmbH K161312Sysmex Automated Blood Coagulation Analyzer CS-2100iSiemens Healthcare Diagnostics Products GmbH K151259Sysmex Automated Blood Coagulation Analyzer CS-2100iSiemens Healthcare Diagnostics Products GmbH K172286Automated Blood Coagulation Analyzer CS-2500Siemens Healthcare Diagnostic Products GmbH

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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