MARDX MITOCHONDRIA EIA TEST SYSTEM— 510(k) K950110

Name: FDA 510(k) clearance K950110
Creator: U.S. Food and Drug Administration
Published: 1995-05-15

Substantially Equivalent

Hogan & Hartson

FDA 510(k) clearance K950110 for MARDX MITOCHONDRIA EIA TEST SYSTEM, Substantially Equivalent on 1995-05-15. Applicant: Hogan & Hartson. Device class: 2.

Clearance details

Applicant: Hogan & Hartson
Product code: Code LJM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1995-01-11
Decision date: 1995-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, D.C., DC, US

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