510(k) K012449— DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM

Substantially Equivalent

Diamedix Corp.

Clearance details

Applicant: Diamedix Corp.
Product code: Code MID
Advisory panel: Immunology
Date received: 2001-08-01
Decision date: 2001-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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