THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGM ELISA TEST SYSTEM— 510(k) K984175

Name: FDA 510(k) clearance K984175
Creator: U.S. Food and Drug Administration
Published: 1998-12-17

Substantially Equivalent

Zeus Scientific, Inc.

FDA 510(k) clearance K984175 for THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGM ELISA TEST SYSTEM, Substantially Equivalent on 1998-12-17. 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: 1998-11-20
Decision date: 1998-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

Download summary PDF View on FDA.gov ↗

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