URINE DIAGNOSTIC REAGENT STRIPS— 510(k) K862806

Name: FDA 510(k) clearance K862806
Creator: U.S. Food and Drug Administration
Published: 1986-12-04

Substantially Equivalent

Amatech International, Inc.

FDA 510(k) clearance K862806 for URINE DIAGNOSTIC REAGENT STRIPS, Substantially Equivalent on 1986-12-04. Applicant: Amatech International, Inc.. Device class: 1.

Clearance details

Applicant: Amatech International, Inc.
Product code: Code JJB
Device class: Class 1
Regulation: 21 CFR 862.1115
Advisory panel: Clinical Chemistry
Date received: 1986-07-23
Decision date: 1986-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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