FDA Product Code JBQ: Antithrombin Iii Quantitation
Leading manufacturers include Siemens Healthcare Diagnostic Products GmbH.
FDA 510(k) Cleared Antithrombin Iii Quantitation Devices (Product Code JBQ)
About Product Code JBQ - Regulatory Context
510(k) Submission Activity
56 total 510(k) submissions under product code JBQ since 1977, with 56 receiving FDA clearance (average review time: 102 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under JBQ have taken an average of 184 days to reach a decision - up from 100 days historically. Manufacturers should account for longer review timelines in current project planning.
JBQ devices are reviewed by the Hematology panel. Browse all Hematology devices →