Sysmex Automated Blood Coagulation Analyzer CS-5100— 510(k) K161317

Clearance details

Applicant

Siemens Healthcare Diagnostics Products GmbH

Product code

Code JPA

Device class

Class 2

Regulation

21 CFR 864.5425

Advisory panel

Hematology

Date received

2016-05-11

Decision date

2016-09-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Marburg, DE

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Death

6

Total

6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →