V-TREND BETA-HCG DRY-SPOT TEST— 510(k) K875262

Name: FDA 510(k) clearance K875262
Creator: U.S. Food and Drug Administration
Published: 1988-02-02

Substantially Equivalent

Texas Immunology, Inc.

FDA 510(k) clearance K875262 for V-TREND BETA-HCG DRY-SPOT TEST, Substantially Equivalent on 1988-02-02. Applicant: Texas Immunology, Inc.. Device class: 2.

Clearance details

Applicant: Texas Immunology, Inc.
Product code: Code JHJ
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1987-12-22
Decision date: 1988-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tyler, TX, US

Download summary PDF View on FDA.gov ↗

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