Cleared Traditional

TRIAGE PROFILER S.O.B. PANEL

K040437 · Biosite Incorporated · Chemistry

Jun 2004

Decision

127d

Days

Class 2

Risk

About This 510(k) Submission

K040437 is an FDA 510(k) clearance for the TRIAGE PROFILER S.O.B. PANEL, a Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (Class II — Special Controls, product code DAP), submitted by Biosite Incorporated (San Diego, US). The FDA issued a Cleared decision on June 25, 2004, 127 days after receiving the submission on February 19, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number	K040437 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 19, 2004
Decision Date	June 25, 2004
Days to Decision	127 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
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