Cleared Traditional

TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300

K042723 · Biosite Incorporated · Chemistry

Dec 2004

Decision

67d

Days

Class 2

Risk

About This 510(k) Submission

K042723 is an FDA 510(k) clearance for the TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300, 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 December 7, 2004, 67 days after receiving the submission on October 1, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number	K042723 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 01, 2004
Decision Date	December 07, 2004
Days to Decision	67 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