IMMUNOTECH HDL-CHOLESTEROL TEST— 510(k) K900036

Name: FDA 510(k) clearance K900036
Creator: U.S. Food and Drug Administration
Published: 1990-03-09

Substantially Equivalent

Immunotech Corp.

FDA 510(k) clearance K900036 for IMMUNOTECH HDL-CHOLESTEROL TEST, Substantially Equivalent on 1990-03-09. Applicant: Immunotech Corp.. Device class: 1.

Clearance details

Applicant: Immunotech Corp.
Product code: Code LBS
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1990-01-02
Decision date: 1990-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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