DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM— 510(k) K012450

Name: FDA 510(k) clearance K012450
Creator: U.S. Food and Drug Administration
Published: 2001-10-26

Substantially Equivalent

Diamedix Corp.

FDA 510(k) clearance K012450 for DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM, Substantially Equivalent on 2001-10-26. Applicant: Diamedix Corp.. Device class: 2.

Clearance details

Applicant: Diamedix Corp.
Product code: Code MID
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 2001-08-01
Decision date: 2001-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.