Cleared Traditional

Xprecia Stride Coagulation System, Xprecia System PT Controls

K151964 · Siemens Healthcare Diagnostics · Hematology
Sep 2016
Decision
442d
Days
Class 2
Risk

About This 510(k) Submission

K151964 is an FDA 510(k) clearance for the Xprecia Stride Coagulation System, Xprecia System PT Controls, a Test, Time, Prothrombin (Class II — Special Controls, product code GJS), submitted by Siemens Healthcare Diagnostics (Norowood, US). The FDA issued a Cleared decision on September 30, 2016, 442 days after receiving the submission on July 16, 2015. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number K151964 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 2015
Decision Date September 30, 2016
Days to Decision 442 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GJS — Test, Time, Prothrombin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7750

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