ENDAB THEOPHYLLINE ENZYME IMMUNOASSAY— 510(k) K802066

Name: FDA 510(k) clearance K802066
Creator: U.S. Food and Drug Administration
Published: 1980-10-23

Substantially Equivalent

Immunotech Corp.

FDA 510(k) clearance K802066 for ENDAB THEOPHYLLINE ENZYME IMMUNOASSAY, Substantially Equivalent on 1980-10-23. Applicant: Immunotech Corp.. Device class: 2.

Clearance details

Applicant: Immunotech Corp.
Product code: Code KLS
Device class: Class 2
Regulation: 21 CFR 862.3880
Advisory panel: Clinical Toxicology
Date received: 1980-08-27
Decision date: 1980-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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