ENDAB T4 ENZYME IMMUNOASSAY KIT— 510(k) K821141

Name: FDA 510(k) clearance K821141
Creator: U.S. Food and Drug Administration
Published: 1982-05-13

Substantially Equivalent

Immunotech Corp.

FDA 510(k) clearance K821141 for ENDAB T4 ENZYME IMMUNOASSAY KIT, Substantially Equivalent on 1982-05-13. Applicant: Immunotech Corp.. Device class: 2.

Clearance details

Applicant: Immunotech Corp.
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1982-04-21
Decision date: 1982-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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