V-TREND IM DRY-SPOT TEST— 510(k) K880399

Name: FDA 510(k) clearance K880399
Creator: U.S. Food and Drug Administration
Published: 1988-02-17

Substantially Equivalent

Texas Immunology, Inc.

FDA 510(k) clearance K880399 for V-TREND IM DRY-SPOT TEST, Substantially Equivalent on 1988-02-17. Applicant: Texas Immunology, Inc.. Device class: 2.

Clearance details

Applicant: Texas Immunology, Inc.
Product code: Code KTN
Device class: Class 2
Regulation: 21 CFR 866.5640
Advisory panel: Immunology
Date received: 1988-01-29
Decision date: 1988-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tyler, TX, US

Download summary PDF View on FDA.gov ↗

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