Cleared Traditional

TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS

K062840 · Biosite Incorporated · Hematology
Mar 2007
Decision
160d
Days
Class 2
Risk

About This 510(k) Submission

K062840 is an FDA 510(k) clearance for the TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS, a Plasma, Coagulation Control (Class II — Special Controls, product code GGN), submitted by Biosite Incorporated (San Deigo, US). The FDA issued a Cleared decision on March 1, 2007, 160 days after receiving the submission on September 22, 2006. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K062840 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2006
Decision Date March 01, 2007
Days to Decision 160 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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