GTI-FVIII INHIBITOR ASSAY— 510(k) K993553

Name: FDA 510(k) clearance K993553
Creator: U.S. Food and Drug Administration
Published: 2000-02-01

Substantially Equivalent

Genetic Testing Institute

FDA 510(k) clearance K993553 for GTI-FVIII INHIBITOR ASSAY, Substantially Equivalent on 2000-02-01. Applicant: Genetic Testing Institute. Device class: 2.

Clearance details

Applicant: Genetic Testing Institute
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1999-10-20
Decision date: 2000-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brookfield, WI, US

Download summary PDF View on FDA.gov ↗

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