SERO/TEX LE TEST— 510(k) K821385

Substantially Equivalent

Texas Immunology, Inc.

FDA 510(k) clearance K821385 for SERO/TEX LE TEST, Substantially Equivalent on 1982-05-28. Applicant: Texas Immunology, Inc.. Device class: 2.

Clearance details

Applicant: Texas Immunology, Inc.
Product code: Code DHC
Device class: Class 2
Regulation: 21 CFR 866.5820
Advisory panel: Immunology
Date received: 1982-05-10
Decision date: 1982-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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