HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM— 510(k) K841021

Name: FDA 510(k) clearance K841021
Creator: U.S. Food and Drug Administration
Published: 1984-05-25

Substantially Equivalent

Hemotec, Inc.

FDA 510(k) clearance K841021 for HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM, Substantially Equivalent on 1984-05-25. Applicant: Hemotec, Inc.. Device class: 2.

Clearance details

Applicant: Hemotec, Inc.
Product code: Code JOX
Device class: Class 2
Regulation: 21 CFR 864.5680
Advisory panel: Hematology
Date received: 1984-03-12
Decision date: 1984-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JOX

view all

K111339 — HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)2011-06-08
K102953 — HEPARIN DOSE RESPONSE CARTRIDGE2010-11-04
K101271 — HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX2010-10-13
K051040 — HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR2005-05-24
K043080 — HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR2004-12-03

More clearances from Hemotec, Inc.

view all

K902081 — CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL1990-07-03
K894317 — HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.1989-09-05
K894359 — CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS1989-09-05
K894466 — HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLS1989-09-05
K884590 — HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES1989-01-10

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