CARDIOLIPIN IGG,M,A EIA TEST SYSTEM— 510(k) K951363

Name: FDA 510(k) clearance K951363
Creator: U.S. Food and Drug Administration
Published: 1995-10-13

Substantially Equivalent

Immunoprobe, Inc.

FDA 510(k) clearance K951363 for CARDIOLIPIN IGG,M,A EIA TEST SYSTEM, Substantially Equivalent on 1995-10-13. 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: 1995-03-24
Decision date: 1995-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, D.C., DC, US

Download summary PDF View on FDA.gov ↗

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