Cleared Traditional

TRIAGE STATMETER

K973547 · Biosite Incorporated · Chemistry
Jan 1998
Decision
117d
Days
Class 1
Risk

About This 510(k) Submission

K973547 is an FDA 510(k) clearance for the TRIAGE STATMETER, a Fluorometer, For Clinical Use (Class I — General Controls, product code KHO), submitted by Biosite Incorporated (San Diego, US). The FDA issued a Cleared decision on January 13, 1998, 117 days after receiving the submission on September 18, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2560.

Submission Details

510(k) Number K973547 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 1997
Decision Date January 13, 1998
Days to Decision 117 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code KHO — Fluorometer, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2560

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