FDA Product Code JBP: Activated Whole Blood Clotting Time
Leading manufacturers include 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
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.
JBP devices are reviewed by the Hematology panel. Browse all Hematology devices →