HEMOCHRON(R) KACT— 510(k) K913861

Name: FDA 510(k) clearance K913861
Creator: U.S. Food and Drug Administration
Published: 1991-10-18

Substantially Equivalent

International Technidyne Corp.

FDA 510(k) clearance K913861 for HEMOCHRON(R) KACT, Substantially Equivalent on 1991-10-18. Applicant: International Technidyne Corp.. Device class: 2.

Clearance details

Applicant: International Technidyne Corp.
Product code: Code JBP
Device class: Class 2
Regulation: 21 CFR 864.7140
Advisory panel: Hematology
Date received: 1991-08-27
Decision date: 1991-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edison, NJ, US

Download summary PDF View on FDA.gov ↗

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