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)

Sysmex CS-5100

K-Number: K172333 · 2017-10-31

ApplicantSiemens Healthcare Diagnostics Products GmbH
Decision Date2017-10-31
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Sysmex CS-5100 is a medical device manufactured by Siemens Healthcare Diagnostics Products GmbH. It received FDA 510(k) clearance on 2017-10-31 under approval number K172333. 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 CS-5100?

Sysmex CS-5100 is a medical device that received FDA 510(k) clearance on 2017-10-31. It is manufactured by Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K172333.

When was Sysmex CS-5100 approved by the FDA?

Sysmex CS-5100 received FDA 510(k) clearance on 2017-10-31, under approval number K172333.

What company makes Sysmex CS-5100?

Sysmex CS-5100 is manufactured by Siemens Healthcare Diagnostics Products GmbH.

What is the FDA product code for Sysmex CS-5100?

The FDA product code for Sysmex CS-5100 is JPA.

Other Devices by Siemens Healthcare Diagnostics Products GmbH

K162688Sysmex CS-2100i K162420Sysmex Automated Blood Coagulation Analyzer CS-5100 K161317Sysmex Automated Blood Coagulation Analyzer CS-5100 K161312Sysmex Automated Blood Coagulation Analyzer CS-2100i K151259Sysmex Automated Blood Coagulation Analyzer CS-2100i K171742N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2

View all 19 devices →

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 K150678Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens 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.

↑