FDA Product Code KFF: Assay, Heparin
Leading manufacturers include Instrumentation Laboratory CO.
46
Total
46
Cleared
206d
Avg days
1979
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Assay, Heparin Devices (Product Code KFF)
46 devices
About Product Code KFF - Regulatory Context
510(k) Submission Activity
46 total 510(k) submissions under product code KFF since 1979, with 46 receiving FDA clearance (average review time: 206 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
KFF devices are reviewed by the Hematology panel. Browse all Hematology devices →