Cleared Traditional

Automated Blood Coagulation Analyzer CS-2500

K172286 · Siemens Healthcare Diagnostic Products GmbH · Hematology
Dec 2017
Decision
143d
Days
Class 2
Risk

About This 510(k) Submission

K172286 is an FDA 510(k) clearance for the Automated Blood Coagulation Analyzer CS-2500, 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 December 18, 2017, 143 days after receiving the submission on July 28, 2017. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K172286 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 2017
Decision Date December 18, 2017
Days to Decision 143 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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