HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE— 510(k) K974799

Name: FDA 510(k) clearance K974799
Creator: U.S. Food and Drug Administration
Published: 1998-07-07

Substantially Equivalent

International Technidyne Corp.

FDA 510(k) clearance K974799 for HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE, Substantially Equivalent on 1998-07-07. Applicant: International Technidyne Corp.. Device class: 2.

Clearance details

Applicant: International Technidyne Corp.
Product code: Code JPA
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 1997-12-22
Decision date: 1998-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edison, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JPA

view all

K253658 — STA Satellite Max®2026-04-27
K250965 — Automated Blood Coagulation Analyzer CN-Series (CN-6000)2025-06-02
K251024 — TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge2025-04-30
K243858 — TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge2025-01-15
K232018 — Citrated: K, KH, RTH, FFH2024-03-29

More clearances from International Technidyne Corp.

view all

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 JPA

product code JPA

Death: 6
Total: 6

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.