V-TREND QC TDM CONTROL SERUM 1,2,3.— 510(k) K862817

Name: FDA 510(k) clearance K862817
Creator: U.S. Food and Drug Administration
Published: 1986-08-19

Substantially Equivalent

Texas Immunology, Inc.

FDA 510(k) clearance K862817 for V-TREND QC TDM CONTROL SERUM 1,2,3., Substantially Equivalent on 1986-08-19. Applicant: Texas Immunology, Inc.. Device class: 1.

Clearance details

Applicant: Texas Immunology, Inc.
Product code: Code DIF
Device class: Class 1
Regulation: 21 CFR 862.3280
Advisory panel: Clinical Toxicology
Date received: 1986-07-24
Decision date: 1986-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tyler, TX, US

Download summary PDF View on FDA.gov ↗

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