HEMOCHRON MODEL 8000/FACTOR VI PREMIER COAGULATION— 510(k) K930068

Name: FDA 510(k) clearance K930068
Creator: U.S. Food and Drug Administration
Published: 1993-09-02

Substantially Equivalent

Technidyne Corp.

FDA 510(k) clearance K930068 for HEMOCHRON MODEL 8000/FACTOR VI PREMIER COAGULATION, Substantially Equivalent on 1993-09-02. Applicant: Technidyne Corp.. Device class: 2.

Clearance details

Applicant: Technidyne Corp.
Product code: Code JPA
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 1993-01-06
Decision date: 1993-09-02
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 Technidyne Corp.

view all

K930235 — HEMOCHRON/FACTOR VI WHOLE BLOOD FACTOR VIII ASSAY1993-09-02

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.