DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM— 510(k) K012053

Substantially Equivalent

Diamedix Corp.

FDA 510(k) clearance K012053 for DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM, Substantially Equivalent on 2001-08-20. Applicant: Diamedix Corp..

Clearance details

Applicant: Diamedix Corp.
Product code: Code MID
Advisory panel: Immunology
Date received: 2001-07-02
Decision date: 2001-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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