DeviceClearance

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

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..

Clearance details

Applicant
Mardx Diagnostics, Inc.
Product code
Code LLL
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Carlsbad, CA, US
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