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

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 the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostic Products GmbH. It received FDA 510(k) clearance on 2016-01-11 under 510(k) 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. The listed applicant is Siemens Healthcare Diagnostic Products GmbH. The 510(k) number is K150678.

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 2016-01-11, under 510(k) number K150678.

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

The FDA 510(k) record lists Siemens Healthcare Diagnostic 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.

Other records listing Siemens Healthcare Diagnostic Products GmbH 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.

K253985INNOVANCE® D-Dimer 2.0 (SMN 10873803)K242952INNOVANCE AntithrombinK232624CardioPhase® hsCRPK172286Automated Blood Coagulation Analyzer CS-2500

Related Devices (Code: JPA)

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.

K253658STA Satellite Max®Diagnostica Stago, Inc.K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)Sysmex America, Inc.K251024TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemoneticsK243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics CorporationK232018Citrated: K, KH, RTH, FFHHaemonetics CorporationK233790ACL TOP 970 CLInstrumentation Laboratory

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.

↑