MARDX LYME DISEASE IFA (IGM) TEST SYSTEM— 510(k) K894609

Name: FDA 510(k) clearance K894609
Creator: U.S. Food and Drug Administration
Published: 1989-09-19

Substantially Equivalent

Mardx, Inc.

FDA 510(k) clearance K894609 for MARDX LYME DISEASE IFA (IGM) TEST SYSTEM, Substantially Equivalent on 1989-09-19. Applicant: Mardx, Inc.. Device class: 2.

Clearance details

Applicant: Mardx, Inc.
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1989-07-20
Decision date: 1989-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scotch Plains, NJ, US

Download summary PDF View on FDA.gov ↗

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