Cleared Traditional

DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE

K990873 · Ameritek, Inc. · Chemistry
Sep 1999
Decision
169d
Days
Class 1
Risk

About This 510(k) Submission

K990873 is an FDA 510(k) clearance for the DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE, a Diazo (colorimetric), Nitrite (urinary, Non-quant) (Class I — General Controls, product code JMT), submitted by Ameritek, Inc. (Seattle, US). The FDA issued a Cleared decision on September 1, 1999, 169 days after receiving the submission on March 16, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1510.

Submission Details

510(k) Number K990873 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 1999
Decision Date September 01, 1999
Days to Decision 169 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JMT — Diazo (colorimetric), Nitrite (urinary, Non-quant)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1510

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