Cleared Traditional

URS-1K (KETONE TESST)

K003987 · Teco Diagnostics · Chemistry
Apr 2001
Decision
121d
Days
Class 1
Risk

About This 510(k) Submission

K003987 is an FDA 510(k) clearance for the URS-1K (KETONE TESST), a Nitroprusside, Ketones (urinary, Non-quant.) (Class I — General Controls, product code JIN), submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on April 26, 2001, 121 days after receiving the submission on December 26, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1435.

Submission Details

510(k) Number K003987 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2000
Decision Date April 26, 2001
Days to Decision 121 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JIN — Nitroprusside, Ketones (urinary, Non-quant.)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1435

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