Cleared Traditional

STRATUS CS ACUTE CARE D-DIMER

K110303 · Siemens Healthcare Diagnostics · Hematology
May 2011
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K110303 is an FDA 510(k) clearance for the STRATUS CS ACUTE CARE D-DIMER, a Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (Class II — Special Controls, product code DAP), submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on May 16, 2011, 104 days after receiving the submission on February 1, 2011. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number K110303 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2011
Decision Date May 16, 2011
Days to Decision 104 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code DAP — Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7320

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