UREA NITROGEN TEST (BUN) ITEM #65408— 510(k) K894378

Name: FDA 510(k) clearance K894378
Creator: U.S. Food and Drug Administration
Published: 1989-08-31

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K894378 for UREA NITROGEN TEST (BUN) ITEM #65408, Substantially Equivalent on 1989-08-31. 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: 1989-07-17
Decision date: 1989-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

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