1URO-LOG HOME DIAGNOSTIC PACK— 510(k) K844338

Name: FDA 510(k) clearance K844338
Creator: U.S. Food and Drug Administration
Published: 1985-02-25

Substantially Equivalent

Epcom Medical Systems, Inc.

FDA 510(k) clearance K844338 for 1URO-LOG HOME DIAGNOSTIC PACK, Substantially Equivalent on 1985-02-25. Applicant: Epcom Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Epcom Medical Systems, Inc.
Product code: Code FFG
Device class: Class 2
Regulation: 21 CFR 876.1800
Advisory panel: Gastroenterology, Urology
Date received: 1984-11-08
Decision date: 1985-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, CA, US

Download summary PDF View on FDA.gov ↗

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