HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT— 510(k) K960749

Name: FDA 510(k) clearance K960749
Creator: U.S. Food and Drug Administration
Published: 1996-08-12

Substantially Equivalent

International Technidyne Corp.

FDA 510(k) clearance K960749 for HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT, Substantially Equivalent on 1996-08-12. 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: 1996-02-23
Decision date: 1996-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edison, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JBP

view all

K223635 — Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer2023-01-04
K062604 — RAPIDTEG TEG-ACT TEST2007-01-31
K032952 — AIACT KIT2003-12-12
K023582 — I-STAT KAOLIN ACT TEST2003-09-08
K020914 — ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 57702002-05-23

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

Recalls naming K960749

K-number listed on FDA's recall record

Z-0880-2026 — Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation SystemClass II·Ongoing·Accriva Diagnostics, Inc.·20251105

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K960749.

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