FDA Product Code JBP: Activated Whole Blood Clotting Time
Leading manufacturers include Helena Laboratories, Sienco, Inc. and Roche Diagnostics Corp..
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
Cleared
Jan 04, 2023
Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer
Sienco, Inc.
Hematology
30d
Cleared
May 23, 2002
ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770
Helena Laboratories
Hematology
63d
Cleared
Jan 10, 2002
ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752
Helena Laboratories
Hematology
118d
Cleared
Jan 14, 2000
ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM
Roche Diagnostics Corp.
Hematology
143d
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.