FDA Product Code JBF: Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening
Leading manufacturers include Baebies, Inc..
5
Total
5
Cleared
401d
Avg days
1995
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening Devices (Product Code JBF)
5 devices
About Product Code JBF - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code JBF since 1995, with 5 receiving FDA clearance (average review time: 401 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
JBF devices are reviewed by the Hematology panel. Browse all Hematology devices →