IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96— 510(k) K020583

Name: FDA 510(k) clearance K020583
Creator: U.S. Food and Drug Administration
Published: 2002-09-17

Substantially Equivalent

Ivd Research, Inc.

FDA 510(k) clearance K020583 for IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96, Substantially Equivalent on 2002-09-17. Applicant: Ivd Research, Inc.. Device class: 2.

Clearance details

Applicant: Ivd Research, Inc.
Product code: Code MHI
Device class: Class 2
Regulation: 21 CFR 866.3220
Advisory panel: Microbiology
Date received: 2002-02-21
Decision date: 2002-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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