Product code JBP— Hematology

FDA has cleared 24 devices under product code JBP between 1979 and 2023, filed by 15 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20231 clearance
• 20071 clearance
• 20032 clearances
• 20022 clearances
• 20004 clearances
• 19991 clearance
• 19981 clearance
• 19972 clearances
• 19961 clearance
• 19941 clearance
• 19921 clearance
• 19911 clearance
• 19901 clearance
• 19862 clearances
• 19841 clearance

• Sienco, Inc.4 clearances
• International Technidyne Corp.4 clearances
• Hemotec, Inc.2 clearances
• Helena Laboratories2 clearances
• Array Medical, Inc.2 clearances
• Tri-Med, Inc.1 clearance
• Roche Diagnostics Corp.1 clearance
• Medtronic Hemotec, Inc.1 clearance
• Medical Device Consultants, Inc.1 clearance
• I-Stat Corporation1 clearance

• K223635 — Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot ViewerSienco, Inc.·2023-01-04
• K062604 — RAPIDTEG TEG-ACT TESTHaemoscope Corp.·2007-01-31
• K032952 — AIACT KITSienco, Inc.·2003-12-12
• K023582 — I-STAT KAOLIN ACT TESTI-Stat Corporation·2003-09-08
• K020914 — ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770Helena Laboratories·2002-05-23
• K013078 — ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752Helena Laboratories·2002-01-10
• K002528 — SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTIONSienco, Inc.·2000-08-31
• K994194 — (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINTCardiovascular Diagnostics, Inc.·2000-03-28
• K992571 — I-STAT SYSTEMI-Stat Corp.·2000-02-10
• K992851 — ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEMRoche Diagnostics Corp.·2000-01-14
• K984141 — GBACT + KITSienco, Inc.·1999-05-28
• K983649 — MAX-ACTArray Medical, Inc.·1998-12-11
• K971935 — B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN)B & D Corp.·1997-10-01
• K964609 — ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBEArray Medical, Inc.·1997-03-06
• K960749 — HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACTInternational Technidyne Corp.·1996-08-12
• K941007 — CATALOG NO. J-ACT+ & QC-ACT+International Technidyne Corp.·1994-06-30
• K923594 — CLOTTRAC COAGULATION CONTROLMedtronic Hemotec, Inc.·1992-09-21
• K913861 — HEMOCHRON(R) KACTInternational Technidyne Corp.·1991-10-18
• K902081 — CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROLHemotec, Inc.·1990-07-03
• K854686 — TE-25 COAGURO METERFuture Impex Corp.·1986-06-04
• K860122 — HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIMEMedical Device Consultants, Inc.·1986-04-04
• K843459 — HEMOTEC ACT I SYSTEMHemotec, Inc.·1984-12-12
• K832189 — HEMOCHRON THROMBOCHRONOMETERInternational Technidyne Corp.·1983-10-14
• K790346 — ACTIVATORTri-Med, Inc.·1979-03-21