MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT— 510(k) K903359

Name: FDA 510(k) clearance K903359
Creator: U.S. Food and Drug Administration
Published: 1990-08-22

Substantially Equivalent

Immunotech Corp.

FDA 510(k) clearance K903359 for MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT, Substantially Equivalent on 1990-08-22. Applicant: Immunotech Corp.. Device class: 1.

Clearance details

Applicant: Immunotech Corp.
Product code: Code CGI
Device class: Class 1
Regulation: 21 CFR 862.1265
Advisory panel: Clinical Chemistry
Date received: 1990-07-25
Decision date: 1990-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, 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.