DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE— 510(k) K990873

Name: FDA 510(k) clearance K990873
Creator: U.S. Food and Drug Administration
Published: 1999-09-01

Substantially Equivalent

Ameritek, Inc.

FDA 510(k) clearance K990873 for DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE, Substantially Equivalent on 1999-09-01. Applicant: Ameritek, Inc.. Device class: 1.

Clearance details

Applicant: Ameritek, Inc.
Product code: Code JMT
Device class: Class 1
Regulation: 21 CFR 862.1510
Advisory panel: Clinical Chemistry
Date received: 1999-03-16
Decision date: 1999-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

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