DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM— 510(k) K013628

Substantially Equivalent

Diamedix Corp.

FDA 510(k) clearance K013628 for DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM, Substantially Equivalent on 2001-12-21. Applicant: Diamedix Corp..

Clearance details

Applicant: Diamedix Corp.
Product code: Code MSV
Advisory panel: Immunology
Date received: 2001-11-05
Decision date: 2001-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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