125 I-T4 RIA TEST KIT— 510(k) K811070

Name: FDA 510(k) clearance K811070
Creator: U.S. Food and Drug Administration
Published: 1981-04-29

Substantially Equivalent

Intl. Immunoassay Laboratories, Inc.

FDA 510(k) clearance K811070 for 125 I-T4 RIA TEST KIT, Substantially Equivalent on 1981-04-29. Applicant: Intl. Immunoassay Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Intl. Immunoassay Laboratories, Inc.
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1981-04-20
Decision date: 1981-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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