FDA Product Code JBF: Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening
Leading manufacturers include Pointe Scientific, Inc.,, Binax, Inc. and Alere Scarborough, Inc..
5
Total
5
Cleared
401d
Avg days
1995
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening Devices (Product Code JBF)
5 devices
Cleared
Sep 14, 2022
FINDER G6PD
Baebies, Inc.
Hematology
876d
Cleared
Jun 17, 2016
BinaxNOW G6PD Test
Alere Scarborough, Inc.
Hematology
31d
Cleared
Oct 23, 2008
BINAXNOW G6PD TEST
Binax, Inc.
Hematology
295d
Cleared
Mar 31, 2003
G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE
Pointe Scientific, Inc.,
Chemistry
117d
Cleared
Jun 29, 1995
GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A
Sigma Diagnostics, Inc.
Hematology
687d
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 remained relatively stable over the observed period, with 0 submissions in the last 24 months.