ENA SCREEN ELISA TEST SYSTEM— 510(k) K941014

Name: FDA 510(k) clearance K941014
Creator: U.S. Food and Drug Administration
Published: 1994-06-10

Substantially Equivalent

Zeus Scientific, Inc.

FDA 510(k) clearance K941014 for ENA SCREEN ELISA TEST SYSTEM, Substantially Equivalent on 1994-06-10. Applicant: Zeus Scientific, Inc.. Device class: 2.

Clearance details

Applicant: Zeus Scientific, Inc.
Product code: Code LJM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1994-03-03
Decision date: 1994-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raritan, NJ, US

Download summary PDF View on FDA.gov ↗

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