MICRO DAU OPIATE ENZYME IMMUNOASSAY KIT— 510(k) K902194

Name: FDA 510(k) clearance K902194
Creator: U.S. Food and Drug Administration
Published: 1990-07-17

Substantially Equivalent

Immunotech Corp.

FDA 510(k) clearance K902194 for MICRO DAU OPIATE ENZYME IMMUNOASSAY KIT, Substantially Equivalent on 1990-07-17. Applicant: Immunotech Corp.. Device class: 2.

Clearance details

Applicant: Immunotech Corp.
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 1990-05-16
Decision date: 1990-07-17
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.