MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM— 510(k) K964787

Name: FDA 510(k) clearance K964787
Creator: U.S. Food and Drug Administration
Published: 1997-04-08

Substantially Equivalent

Mardx Diagnostics, Inc.

FDA 510(k) clearance K964787 for MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM, Substantially Equivalent on 1997-04-08. Applicant: Mardx Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Mardx Diagnostics, Inc.
Product code: Product code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1996-11-29
Decision date: 1997-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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