V-TREND ASO PLUS LATEX TEST— 510(k) K853857

Name: FDA 510(k) clearance K853857
Creator: U.S. Food and Drug Administration
Published: 1985-10-16

Substantially Equivalent

Texas Immunology, Inc.

FDA 510(k) clearance K853857 for V-TREND ASO PLUS LATEX TEST, Substantially Equivalent on 1985-10-16. Applicant: Texas Immunology, Inc.. Device class: 1.

Clearance details

Applicant: Texas Immunology, Inc.
Product code: Code GTQ
Device class: Class 1
Regulation: 21 CFR 866.3720
Advisory panel: Microbiology
Date received: 1985-09-16
Decision date: 1985-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tyler, TX, US

Download summary PDF View on FDA.gov ↗

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