HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION— 510(k) K904454

Name: FDA 510(k) clearance K904454
Creator: U.S. Food and Drug Administration
Published: 1990-12-17

Substantially Equivalent

International Technidyne Corp.

FDA 510(k) clearance K904454 for HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION, Substantially Equivalent on 1990-12-17. Applicant: International Technidyne Corp.. Device class: 2.

Clearance details

Applicant: International Technidyne Corp.
Product code: Code GJS
Device class: Class 2
Regulation: 21 CFR 864.7750
Advisory panel: Hematology
Date received: 1990-09-17
Decision date: 1990-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edison, NJ, US

Download summary PDF View on FDA.gov ↗

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K120977 — DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC2013-07-03
K050016 — HEMOCHRON SIGNATURE ELITE2005-02-10
K030818 — HEMOCHRON RESPONSE/SYSTEM2003-04-02
K023561 — ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM2003-01-31
K020798 — HEMOCHRON JR. SIGNATURE +2002-03-28

Adverse events under product code GJS

product code GJS

Death: 4
Injury: 229
Malfunction: 4,852
Total: 5,085

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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