ATHENA MULTI-LYTE ANA-II TEST SYSTEM— 510(k) K042416

Name: FDA 510(k) clearance K042416
Creator: U.S. Food and Drug Administration
Published: 2004-10-08

Substantially Equivalent

Zeus Scientific, Inc.

FDA 510(k) clearance K042416 for ATHENA MULTI-LYTE ANA-II TEST SYSTEM, Substantially Equivalent on 2004-10-08. Applicant: Zeus Scientific, Inc.. Device class: 2.

Clearance details

Applicant: Zeus Scientific, Inc.
Product code: Code LKJ
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2004-09-07
Decision date: 2004-10-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Raritan, NJ, US

Download summary PDF View on FDA.gov ↗

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