PREG/TEX PREGNANCY TEST— 510(k) K821387

Substantially Equivalent

Texas Immunology, Inc.

FDA 510(k) clearance K821387 for PREG/TEX PREGNANCY TEST, Substantially Equivalent on 1982-06-02. 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: 1982-05-10
Decision date: 1982-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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