DRUG CHECK— 510(k) K980153

Substantially Equivalent

Texas Immunology, Inc.

FDA 510(k) clearance K980153 for DRUG CHECK, Substantially Equivalent on 1998-03-27. Applicant: Texas Immunology, Inc.. Device class: 2.

Clearance details

Applicant: Texas Immunology, Inc.
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 1998-01-16
Decision date: 1998-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tyler, TX, US

Download summary PDF View on FDA.gov ↗

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