COUNT-10 SYSTEM FOR STAND. URINALYSIS— 510(k) K823364

Name: FDA 510(k) clearance K823364
Creator: U.S. Food and Drug Administration
Published: 1982-12-15

Substantially Equivalent

V-Tech, Inc.

FDA 510(k) clearance K823364 for COUNT-10 SYSTEM FOR STAND. URINALYSIS, Substantially Equivalent on 1982-12-15. Applicant: V-Tech, Inc.. Device class: 1.

Clearance details

Applicant: V-Tech, Inc.
Product code: Code JQW
Device class: Class 1
Regulation: 21 CFR 862.2750
Advisory panel: Clinical Chemistry
Date received: 1982-11-09
Decision date: 1982-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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