UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE— 510(k) K954514

Name: FDA 510(k) clearance K954514
Creator: U.S. Food and Drug Administration
Published: 1996-06-21

Substantially Equivalent

Sciteck Diagnostics, Inc.

FDA 510(k) clearance K954514 for UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE, Substantially Equivalent on 1996-06-21. Applicant: Sciteck Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Sciteck Diagnostics, Inc.
Product code: Code KQO
Device class: Class 1
Regulation: 21 CFR 862.2900
Advisory panel: Clinical Chemistry
Date received: 1995-09-28
Decision date: 1996-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arden, NC, US

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