510(k) K894224— MARDX LYME DISEASE EIA (IGG) TEST SYSTEM

Substantially Equivalent

Mardx Diagnostics, Inc.

Clearance details

Applicant
Mardx Diagnostics, Inc.
Product code
Code LSR
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Scotch Plains, NJ, US
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