MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM— 510(k) K951709

Name: FDA 510(k) clearance K951709
Creator: U.S. Food and Drug Administration
Published: 1996-06-07

Substantially Equivalent

Mardx Diagnostics, Inc.

FDA 510(k) clearance K951709 for MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM, Substantially Equivalent on 1996-06-07. Applicant: Mardx Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Mardx Diagnostics, Inc.
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1995-04-13
Decision date: 1996-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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