DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM— 510(k) K012797

Substantially Equivalent

Diamedix Corp.

FDA 510(k) clearance K012797 for DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM, Substantially Equivalent on 2001-09-28. Applicant: Diamedix Corp..

Clearance details

Applicant: Diamedix Corp.
Product code: Code MST
Advisory panel: Immunology
Date received: 2001-08-21
Decision date: 2001-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.