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FDA 510(k)

Sysmex Automated Blood Coagulation Analyzer CS-2100i

K-Number: K161312 · 2016-09-01

ApplicantSiemens Healthcare Diagnostics Products GmbH
Decision Date2016-09-01
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Sysmex Automated Blood Coagulation Analyzer CS-2100i is a medical device manufactured by Siemens Healthcare Diagnostics Products GmbH. It received FDA 510(k) clearance on 2016-09-01 under approval number K161312. 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-2100i?

Sysmex Automated Blood Coagulation Analyzer CS-2100i is a medical device that received FDA 510(k) clearance on 2016-09-01. It is manufactured by Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K161312.

When was Sysmex Automated Blood Coagulation Analyzer CS-2100i approved by the FDA?

Sysmex Automated Blood Coagulation Analyzer CS-2100i received FDA 510(k) clearance on 2016-09-01, under approval number K161312.

What company makes Sysmex Automated Blood Coagulation Analyzer CS-2100i?

Sysmex Automated Blood Coagulation Analyzer CS-2100i is manufactured by Siemens Healthcare Diagnostics Products GmbH.

What is the FDA product code for Sysmex Automated Blood Coagulation Analyzer CS-2100i?

The FDA product code for Sysmex Automated Blood Coagulation Analyzer CS-2100i is JPA.

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Related PubMed Literature

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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 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 K172333Sysmex CS-5100

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 K151259Sysmex Automated Blood Coagulation Analyzer CS-2100iSiemens Healthcare Diagnostics Products GmbH K150678Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostic 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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