V-TREND BETA-HCG TEST— 510(k) K874638

Substantially Equivalent

Texas Immunology, Inc.

FDA 510(k) clearance K874638 for V-TREND BETA-HCG TEST, Substantially Equivalent on 1988-01-21. 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: 1987-11-12
Decision date: 1988-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tyler, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.