ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT— 510(k) K803296

Name: FDA 510(k) clearance K803296
Creator: U.S. Food and Drug Administration
Published: 1981-01-16

Substantially Equivalent

Immunotech Corp.

FDA 510(k) clearance K803296 for ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT, Substantially Equivalent on 1981-01-16. Applicant: Immunotech Corp.. Device class: 2.

Clearance details

Applicant: Immunotech Corp.
Product code: Code KWW
Device class: Class 2
Regulation: 21 CFR 862.1177
Advisory panel: Clinical Chemistry
Date received: 1980-12-30
Decision date: 1981-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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