ANTICARDIOLIPIN ANTIBODY TEST SYSTEM— 510(k) K903531

Name: FDA 510(k) clearance K903531
Creator: U.S. Food and Drug Administration
Published: 1991-01-25

Substantially Equivalent

Medical Innovations Corp.

FDA 510(k) clearance K903531 for ANTICARDIOLIPIN ANTIBODY TEST SYSTEM, Substantially Equivalent on 1991-01-25. Applicant: Medical Innovations Corp.. Device class: 2.

Clearance details

Applicant: Medical Innovations Corp.
Product code: Code GFO
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 1990-08-06
Decision date: 1991-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

Download summary PDF View on FDA.gov ↗

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