TRI-LEVEL WHOLE BLOOD LEAD TOXICOLOGY CONTROL— 510(k) K943422

Name: FDA 510(k) clearance K943422
Creator: U.S. Food and Drug Administration
Published: 1994-11-02

Substantially Equivalent

Utak Lab, Inc.

FDA 510(k) clearance K943422 for TRI-LEVEL WHOLE BLOOD LEAD TOXICOLOGY CONTROL, Substantially Equivalent on 1994-11-02. Applicant: Utak Lab, Inc.. Device class: 1.

Clearance details

Applicant: Utak Lab, Inc.
Product code: Code DIF
Device class: Class 1
Regulation: 21 CFR 862.3280
Advisory panel: Clinical Toxicology
Date received: 1994-07-15
Decision date: 1994-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valencia, CA, US

Download summary PDF View on FDA.gov ↗

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