JBP · Activated Whole Blood Clotting Time
Hematology · 21 CFR 864.7140 · Class 2
Overview
| Product Code | JBP |
|---|---|
| Device Name | Activated Whole Blood Clotting Time |
| Regulation | 21 CFR 864.7140 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of venous thrombosis or pulmonary embolism by measuring the coagulation time of whole blood.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 24)
Showing 20 most recent of 24 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K223635 | Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer | Sienco, Inc. | Jan 4, 2023 | SESE |
| K062604 | RAPIDTEG TEG-ACT TEST | Haemoscope Corp. | Jan 31, 2007 | SESE |
| K032952 | AIACT KIT | Sienco, Inc. | Dec 12, 2003 | SESE |
| K023582 | I-STAT KAOLIN ACT TEST | I-Stat Corporation | Sep 8, 2003 | SESE |
| K020914 | ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 | Helena Laboratories | May 23, 2002 | SESE |
| K013078 | ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752 | Helena Laboratories | Jan 10, 2002 | SESE |
| K002528 | SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION | Sienco, Inc. | Aug 31, 2000 | SESE |
| K994194 | (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT | Cardiovascular Diagnostics, Inc. | Mar 28, 2000 | SESE |
| K992571 | I-STAT SYSTEM | I-Stat Corp. | Feb 10, 2000 | SESE |
| K992851 | ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM | Roche Diagnostics Corp. | Jan 14, 2000 | SESE |
| K984141 | GBACT + KIT | Sienco, Inc. | May 28, 1999 | SESE |
| K983649 | MAX-ACT | Array Medical, Inc. | Dec 11, 1998 | SESE |
| K971935 | B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN) | B & D Corp. | Oct 1, 1997 | SESE |
| K964609 | ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE | Array Medical, Inc. | Mar 6, 1997 | SESE |
| K960749 | HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT | International Technidyne Corp. | Aug 12, 1996 | SESE |
| K941007 | CATALOG NO. J-ACT+ & QC-ACT+ | International Technidyne Corp. | Jun 30, 1994 | SESE |
| K923594 | CLOTTRAC COAGULATION CONTROL | Medtronic Hemotec, Inc. | Sep 21, 1992 | SESE |
| K913861 | HEMOCHRON(R) KACT | International Technidyne Corp. | Oct 18, 1991 | SESE |
| K902081 | CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL | Hemotec, Inc. | Jul 3, 1990 | SESE |
| K854686 | TE-25 COAGURO METER | Future Impex Corp. | Jun 4, 1986 | SESE |
Top Applicants
- International Technidyne Corp. — 4 clearances
- Sienco, Inc. — 4 clearances
- Array Medical, Inc. — 2 clearances
- Helena Laboratories — 2 clearances
- Hemotec, Inc. — 2 clearances
