Cleared Traditional

Sysmex Automated Blood Coagulation Analyzer CS-5100

K150678 · Siemens Healthcare Diagnostic Products GmbH · Hematology
Jan 2016
Decision
301d
Days
Class 2
Risk

About This 510(k) Submission

K150678 is an FDA 510(k) clearance for the Sysmex Automated Blood Coagulation Analyzer CS-5100, a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA), submitted by Siemens Healthcare Diagnostic Products GmbH (Marburg, DE). The FDA issued a Cleared decision on January 11, 2016, 301 days after receiving the submission on March 16, 2015. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K150678 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 2015
Decision Date January 11, 2016
Days to Decision 301 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JPA — System, Multipurpose For In Vitro Coagulation Studies
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

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