IVD TECHNOLOGIES ACHRAB TEST KIT— 510(k) K091468

Name: FDA 510(k) clearance K091468
Creator: U.S. Food and Drug Administration
Published: 2009-11-20

Substantially Equivalent

Ivd Technologies

FDA 510(k) clearance K091468 for IVD TECHNOLOGIES ACHRAB TEST KIT, Substantially Equivalent on 2009-11-20. Applicant: Ivd Technologies. Device class: 2.

Clearance details

Applicant: Ivd Technologies
Product code: Code NST
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 2009-05-18
Decision date: 2009-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Stroudsburg, PA, US

Download summary PDF View on FDA.gov ↗

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