ULTRA LYTE ANALYZER I 100— 510(k) K842315

Name: FDA 510(k) clearance K842315
Creator: U.S. Food and Drug Administration
Published: 1984-08-02

Substantially Equivalent

Ultra Quest Diagnostics, Inc.

FDA 510(k) clearance K842315 for ULTRA LYTE ANALYZER I 100, Substantially Equivalent on 1984-08-02. Applicant: Ultra Quest Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Ultra Quest Diagnostics, Inc.
Product code: Code CEM
Device class: Class 2
Regulation: 21 CFR 862.1600
Advisory panel: Clinical Chemistry
Date received: 1984-06-12
Decision date: 1984-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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