GTI-PF4 ELISA— 510(k) K983379

Substantially Equivalent

Genetic Testing Institute

FDA 510(k) clearance K983379 for GTI-PF4 ELISA, Substantially Equivalent on 1999-03-09. Applicant: Genetic Testing Institute. Device class: 2.

Clearance details

Applicant: Genetic Testing Institute
Product code: Code LCO
Device class: Class 2
Regulation: 21 CFR 864.7695
Advisory panel: Hematology
Date received: 1998-09-25
Decision date: 1999-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brookfield, WI, US

Download summary PDF View on FDA.gov ↗

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