UREA NITROGEN TEST— 510(k) K903334

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K903334 for UREA NITROGEN TEST, Substantially Equivalent on 1990-09-07. 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: 1990-07-25
Decision date: 1990-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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K935136 — CHOLESTEROL (CHOL) TEST ITEM NO. 654101993-12-16

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