JBP — Activated Whole Blood Clotting Time Class II
FDA product code JBP covers "Activated Whole Blood Clotting Time", a Class II medical device regulated under 21 CFR 864.7140. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |