Cleared Traditional

TRIAGE D-DIMER TEST, MODEL 98100

K042890 · Biosite Incorporated · Hematology
Nov 2004
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K042890 is an FDA 510(k) clearance for the TRIAGE D-DIMER TEST, MODEL 98100, a Fibrin Split Products (Class II — Special Controls, product code GHH), submitted by Biosite Incorporated (San Diego, US). The FDA issued a Cleared decision on November 29, 2004, 41 days after receiving the submission on October 19, 2004. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number K042890 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 2004
Decision Date November 29, 2004
Days to Decision 41 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GHH — Fibrin Split Products
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7320

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