UREA NITROGEN TEST ITEM NUMBER 65408— 510(k) K932161

Name: FDA 510(k) clearance K932161
Creator: U.S. Food and Drug Administration
Published: 1993-09-08

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K932161 for UREA NITROGEN TEST ITEM NUMBER 65408, Substantially Equivalent on 1993-09-08. Applicant: Em Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1993-05-04
Decision date: 1993-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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