JBP · Class II · 21 CFR 864.7140

FDA Product Code JBP: Activated Whole Blood Clotting Time

Leading manufacturers include International Technidyne Corp., Helena Laboratories and Sienco, Inc..

24
Total
24
Cleared
111d
Avg days
1979
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Activated Whole Blood Clotting Time Devices (Product Code JBP)

24 devices
1–24 of 24
Cleared Jan 04, 2023
Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer
K223635
Sienco, Inc.
Hematology · 30d
Cleared Jan 31, 2007
RAPIDTEG TEG-ACT TEST
K062604
Haemoscope Corp.
Hematology · 152d
Cleared May 23, 2002
ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770
K020914
Helena Laboratories
Hematology · 63d
Cleared Jan 10, 2002
ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752
K013078
Helena Laboratories
Hematology · 118d
Cleared Mar 28, 2000
(TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT
K994194
Cardiovascular Diagnostics, Inc.
Hematology · 106d
Cleared Feb 10, 2000
I-STAT SYSTEM
K992571
I-Stat Corp.
Hematology · 192d
Cleared Jan 14, 2000
ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM
K992851
Roche Diagnostics Corp.
Hematology · 143d
Cleared May 28, 1999
GBACT + KIT
K984141
Sienco, Inc.
Hematology · 191d
Cleared Dec 11, 1998
MAX-ACT
K983649
Array Medical, Inc.
Hematology · 56d
Cleared Oct 01, 1997
B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN)
K971935
B & D Corp.
Hematology · 127d
Cleared Mar 06, 1997
ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE
K964609
Array Medical, Inc.
Hematology · 108d
Cleared Aug 12, 1996
HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT
K960749
International Technidyne Corp.
Hematology · 171d
Cleared Jun 30, 1994
CATALOG NO. J-ACT+ & QC-ACT+
K941007
International Technidyne Corp.
Hematology · 121d
Cleared Oct 18, 1991
HEMOCHRON(R) KACT
K913861
International Technidyne Corp.
Hematology · 52d
Cleared Oct 14, 1983
HEMOCHRON THROMBOCHRONOMETER
K832189
International Technidyne Corp.
Hematology · 98d
Cleared Mar 21, 1979
ACTIVATOR
K790346
Tri-Med, Inc.
Hematology · 28d

About Product Code JBP - Regulatory Context

510(k) Submission Activity

24 total 510(k) submissions under product code JBP since 1979, with 24 receiving FDA clearance (average review time: 111 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.