FDA 510(k)

Sysmex CS-2100i

K-Number: K162688 · 2016-12-26

ApplicantSiemens Healthcare Diagnostics Products GmbH

Decision Date2016-12-26

Product CodeJPA

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

Sysmex CS-2100i 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 2016-12-26 under 510(k) number K162688. 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-2100i?

Sysmex CS-2100i is a medical device that received FDA 510(k) clearance on 2016-12-26. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K162688.

When did Sysmex CS-2100i receive FDA 510(k) clearance?

Sysmex CS-2100i received FDA 510(k) clearance on 2016-12-26, under 510(k) number K162688.

Who is the listed applicant for Sysmex CS-2100i?

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 CS-2100i?

The FDA product code for Sysmex CS-2100i is JPA.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.