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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 4, 2023 | K223635 | Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer Sienco, Inc. | JBP |
| Jan 31, 2007 | K062604 | RAPIDTEG TEG-ACT TEST Haemoscope Corp. | JBP |
| Dec 12, 2003 | K032952 | AIACT KIT Sienco, Inc. | JBP |
| Sep 8, 2003 | K023582 | I-STAT KAOLIN ACT TEST I-Stat Corporation | JBP |
| May 23, 2002 | K020914 | ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 Helena Laboratories | JBP |
| Jan 10, 2002 | K013078 | ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752 Helena Laboratories | JBP |
| Aug 31, 2000 | K002528 | SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION Sienco, Inc. | JBP |
| Mar 28, 2000 | K994194 | (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT Cardiovascular Diagnostics, Inc. | JBP |
| Feb 10, 2000 | K992571 | I-STAT SYSTEM I-Stat Corp. | JBP |
| Jan 14, 2000 | K992851 | ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM Roche Diagnostics Corp. | JBP |
| May 28, 1999 | K984141 | GBACT + KIT Sienco, Inc. | JBP |
| Dec 11, 1998 | K983649 | MAX-ACT Array Medical, Inc. | JBP |
| Oct 1, 1997 | K971935 | B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN) B & D Corp. | JBP |
| Mar 6, 1997 | K964609 | ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE Array Medical, Inc. | JBP |
| Aug 12, 1996 | K960749 | HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT International Technidyne Corp. | JBP |
| Jun 30, 1994 | K941007 | CATALOG NO. J-ACT+ & QC-ACT+ International Technidyne Corp. | JBP |
| Sep 21, 1992 | K923594 | CLOTTRAC COAGULATION CONTROL Medtronic Hemotec, Inc. | JBP |
| Oct 18, 1991 | K913861 | HEMOCHRON(R) KACT International Technidyne Corp. | JBP |
| Jul 3, 1990 | K902081 | CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL Hemotec, Inc. | JBP |
| Jun 4, 1986 | K854686 | TE-25 COAGURO METER Future Impex Corp. | JBP |
| Apr 4, 1986 | K860122 | HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME Medical Device Consultants, Inc. | JBP |
| Dec 12, 1984 | K843459 | HEMOTEC ACT I SYSTEM Hemotec, Inc. | JBP |
| Oct 14, 1983 | K832189 | HEMOCHRON THROMBOCHRONOMETER International Technidyne Corp. | JBP |
| Mar 21, 1979 | K790346 | ACTIVATOR Tri-Med, Inc. | JBP |
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