CARDIOLIPIN IGM EIA TEST SYSTEM— 510(k) K952521

Name: FDA 510(k) clearance K952521
Creator: U.S. Food and Drug Administration
Published: 1996-02-09

Substantially Equivalent

Immunoprobe, Inc.

FDA 510(k) clearance K952521 for CARDIOLIPIN IGM EIA TEST SYSTEM, Substantially Equivalent on 1996-02-09. Applicant: Immunoprobe, Inc.. Device class: 2.

Clearance details

Applicant: Immunoprobe, Inc.
Product code: Code MID
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 1995-06-01
Decision date: 1996-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, D.C., DC, US

Download summary PDF View on FDA.gov ↗

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