FDA Product Code
FDA Product Code JBP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7140
510(k) Clearances — 24 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K223635 | Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer | Sienco, Inc. | 2023-01-04 | Special | PDF ↗ |
| K062604 | RAPIDTEG TEG-ACT TEST | Haemoscope Corp. | 2007-01-31 | Traditional | PDF ↗ |
| K032952 | AIACT KIT | Sienco, Inc. | 2003-12-12 | Traditional | PDF ↗ |
| K023582 | I-STAT KAOLIN ACT TEST | I-Stat Corporation | 2003-09-08 | Traditional | PDF ↗ |
| K020914 | ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 | Helena Laboratories | 2002-05-23 | Traditional | PDF ↗ |
| K013078 | ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752 | Helena Laboratories | 2002-01-10 | Traditional | PDF ↗ |
| K002528 | SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION | Sienco, Inc. | 2000-08-31 | Special | PDF ↗ |
| K994194 | (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT | Cardiovascular Diagnostics, Inc. | 2000-03-28 | Traditional | PDF ↗ |
| K992571 | I-STAT SYSTEM | I-Stat Corp. | 2000-02-10 | Traditional | PDF ↗ |
| K992851 | ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM | Roche Diagnostics Corp. | 2000-01-14 | Traditional | PDF ↗ |
| K984141 | GBACT + KIT | Sienco, Inc. | 1999-05-28 | Special | PDF ↗ |
| K983649 | MAX-ACT | Array Medical, Inc. | 1998-12-11 | Traditional | PDF ↗ |
| K971935 | B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN) | B & D Corp. | 1997-10-01 | Traditional | PDF ↗ |
| K964609 | ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE | Array Medical, Inc. | 1997-03-06 | Traditional | PDF ↗ |
| K960749 | HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT | International Technidyne Corp. | 1996-08-12 | Traditional | PDF ↗ |
| K941007 | CATALOG NO. J-ACT+ & QC-ACT+ | International Technidyne Corp. | 1994-06-30 | Traditional | PDF ↗ |
| K923594 | CLOTTRAC COAGULATION CONTROL | Medtronic Hemotec, Inc. | 1992-09-21 | Traditional | PDF ↗ |
| K913861 | HEMOCHRON(R) KACT | International Technidyne Corp. | 1991-10-18 | Traditional | PDF ↗ |
| K902081 | CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL | Hemotec, Inc. | 1990-07-03 | Traditional | PDF ↗ |
| K854686 | TE-25 COAGURO METER | Future Impex Corp. | 1986-06-04 | Traditional | PDF ↗ |
| K860122 | HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME | Medical Device Consultants, Inc. | 1986-04-04 | Traditional | PDF ↗ |
| K843459 | HEMOTEC ACT I SYSTEM | Hemotec, Inc. | 1984-12-12 | Traditional | PDF ↗ |
| K832189 | HEMOCHRON THROMBOCHRONOMETER | International Technidyne Corp. | 1983-10-14 | Traditional | PDF ↗ |
| K790346 | ACTIVATOR | Tri-Med, Inc. | 1979-03-21 | Traditional | PDF ↗ |
Product code JBP · Class II · Hematology. Data: openFDA.