URIC ACID TEST ITEM NUMBER 65422— 510(k) K932162

Name: FDA 510(k) clearance K932162
Creator: U.S. Food and Drug Administration
Published: 1993-09-27

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K932162 for URIC ACID TEST ITEM NUMBER 65422, Substantially Equivalent on 1993-09-27. Applicant: Em Diagnostic Systems, Inc.. Device class: 1.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CDO
Device class: Class 1
Regulation: 21 CFR 862.1775
Advisory panel: Clinical Chemistry
Date received: 1993-05-04
Decision date: 1993-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

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