ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS— 510(k) K973196

Name: FDA 510(k) clearance K973196
Creator: U.S. Food and Drug Administration
Published: 1997-10-29

Substantially Equivalent

Zeus Scientific, Inc.

FDA 510(k) clearance K973196 for ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS, Substantially Equivalent on 1997-10-29. Applicant: Zeus Scientific, Inc.. Device class: 2.

Clearance details

Applicant: Zeus Scientific, Inc.
Product code: Code MID
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 1997-08-26
Decision date: 1997-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

Download summary PDF View on FDA.gov ↗

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