TT AND HNTT BY HEMOCHRON— 510(k) K900126

Name: FDA 510(k) clearance K900126
Creator: U.S. Food and Drug Administration
Published: 1990-02-05

Substantially Equivalent

International Technidyne Corp.

FDA 510(k) clearance K900126 for TT AND HNTT BY HEMOCHRON, Substantially Equivalent on 1990-02-05. Applicant: International Technidyne Corp.. Device class: 2.

Clearance details

Applicant: International Technidyne Corp.
Product code: Code GJA
Device class: Class 2
Regulation: 21 CFR 864.7875
Advisory panel: Hematology
Date received: 1990-01-09
Decision date: 1990-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edison, NJ, 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.