Cleared Traditional

TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS

K050799 · Biosite Incorporated · Hematology
Jun 2005
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K050799 is an FDA 510(k) clearance for the TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS, a Plasma, Coagulation Control (Class II — Special Controls, product code GGN), submitted by Biosite Incorporated (San Diego, US). The FDA issued a Cleared decision on June 29, 2005, 91 days after receiving the submission on March 30, 2005. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K050799 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 2005
Decision Date June 29, 2005
Days to Decision 91 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGN — Plasma, Coagulation Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

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