COUNT-10 TROL— 510(k) K822540

Substantially Equivalent

Texas Immunology, Inc.

FDA 510(k) clearance K822540 for COUNT-10 TROL, Substantially Equivalent on 1982-10-08. Applicant: Texas Immunology, Inc.. Device class: 1.

Clearance details

Applicant: Texas Immunology, Inc.
Product code: Code JJW
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1982-08-23
Decision date: 1982-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.