REAGENT STRIPS FOR URINALYSIS— 510(k) K811342

Name: FDA 510(k) clearance K811342
Creator: U.S. Food and Drug Administration
Published: 1981-09-01

Substantially Equivalent

Miles Laboratories, Inc.

FDA 510(k) clearance K811342 for REAGENT STRIPS FOR URINALYSIS, Substantially Equivalent on 1981-09-01. Applicant: Miles Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Miles Laboratories, Inc.
Product code: Code JRE
Device class: Class 1
Regulation: 21 CFR 862.2800
Advisory panel: Clinical Chemistry
Date received: 1981-05-12
Decision date: 1981-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

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