Panels › Hematology › Product code JBP · Class 2
Activated Whole Blood Clotting Time
Regulation 864.7140
0510(k)s in 12 months (24 all time)
2recalls in 12 months (10 all time)
10recalls that name a 510(k)
Top companies in JBP
| Company | 510(k)s | Recalls |
|---|---|---|
| International Technidyne Corp. | 4 | 2 |
| Abbott Point Of Care Inc. | 0 | 5 |
| Sienco, Inc. | 4 | 0 |
| Array Medical, Inc. | 2 | 0 |
| Helena Laboratories | 2 | 0 |
| Hemotec, Inc. | 2 | 0 |
| I-Stat Corp. | 2 | 0 |
| Abbott Laboratories | 0 | 1 |
| Accriva Diagnostics, Inc. | 0 | 1 |
| B & D Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 3, 2025 | Accriva Diagnostics, Inc. Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System Open, Classified |
JBP | K960749 |
| Nov 18, 2025 | Medtronic Perfusion Systems Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03 Open, Classified |
JBP | K860122 |
| Feb 16, 2011 | Abbott Point Of Care Inc. Celite ACT Cartridge
Cartridge is useful for monitoring patients receiving heparin for treatment of pulmonary embolism or venous thrombosis, and for monitoring anticoagulation therapy in patients und Terminated |
JBP | K992571 |
| Nov 17, 2010 | Abbott Point Of Care Inc. i-STAT ACT Kaolin Cartridges
in vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery. Terminated |
JBP | K023582 |
| Nov 17, 2010 | Abbott Point Of Care Inc. i-STAT ACT Celite Cartridges
in vitro diagnostic test used to monitor moderate and high-level heparin therapy through analysis of arterial and venous whole blood samples. Terminated |
JBP | K992571 |
| Feb 23, 2010 | Abbott Point of Care Inc. Abbott i-STAT ACT Kaolin Cartridges.
In vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery. Terminated |
JBP | K023582 |
| Feb 23, 2010 | Abbott Point of Care Inc. Abbott i-STAT ACT Celite Cartridges.
In vitro diagnostic test used to monitor moderate and high-level heparin therapy through analysis of arterial and venous whole blood samples. Terminated |
JBP | K992571 |
| Aug 21, 2009 | International Technidyne Corp. Hemochron Jr. ACT- LR Assay (JACT- LR);
ITC Catalogue/Code Number: JACTLR
45 Cuvettes;
For Performance on the HEMOCHROM Whole Blood Microagulation Systems;
International Technidyne Corp., Edison, NJ 0 Terminated |
JBP | K960749 |
| Aug 23, 2005 | International Technidyne Corp. Hemochron Jr. Whole Blood Microcoagulation system Low Range Activated Clotting Time. ACT-LR Cuvettes. In vitro diagnostic use, non-sterile, Packaged in individual foil pouches. 45 foil pouches per Terminated |
JBP | K960749 |
| Jun 21, 2005 | Abbott Laboratories i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test. Terminated |
JBP | K992571 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.