JBP — Activated Whole Blood Clotting Time Class II
FDA Device Classification
Classification Details
- Product Code
- JBP
- Device Class
- Class II
- Regulation Number
- 864.7140
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K223635 | sienco | Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer | January 4, 2023 |
| K062604 | haemoscope | RAPIDTEG TEG-ACT TEST | January 31, 2007 |
| K032952 | sienco | AIACT KIT | December 12, 2003 |
| K023582 | i-stat corporation | I-STAT KAOLIN ACT TEST | September 8, 2003 |
| K020914 | helena laboratories | ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 | May 23, 2002 |
| K013078 | helena laboratories | ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752 | January 10, 2002 |
| K002528 | sienco | SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER O | August 31, 2000 |
| K994194 | cardiovascular diagnostics | (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT | March 28, 2000 |
| K992571 | i-stat | I-STAT SYSTEM | February 10, 2000 |
| K992851 | roche diagnostics | ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYST | January 14, 2000 |
| K984141 | sienco | GBACT + KIT | May 28, 1999 |
| K983649 | array medical | MAX-ACT | December 11, 1998 |
| K971935 | b and d | B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD | October 1, 1997 |
| K964609 | array medical | ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC | March 6, 1997 |
| K960749 | international technidyne | HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT | August 12, 1996 |
| K941007 | international technidyne | CATALOG NO. J-ACT+ & QC-ACT+ | June 30, 1994 |
| K923594 | medtronic hemotec | CLOTTRAC COAGULATION CONTROL | September 21, 1992 |
| K913861 | international technidyne | HEMOCHRON(R) KACT | October 18, 1991 |
| K902081 | hemotec | CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL | July 3, 1990 |
| K854686 | future impex | TE-25 COAGURO METER | June 4, 1986 |