JFP · Class II · 21 CFR 862.1145

FDA Product Code JFP: Electrode, Ion Specific, Calcium

Leading manufacturers include Abbott Point of Care, Inc..

29
Total
29
Cleared
102d
Avg days
1977
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Electrode, Ion Specific, Calcium Devices (Product Code JFP)

29 devices
1–24 of 29
Cleared Oct 27, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K230300
Abbott Point of Care, Inc.
Chemistry · 266d

About Product Code JFP - Regulatory Context

510(k) Submission Activity

29 total 510(k) submissions under product code JFP since 1977, with 29 receiving FDA clearance (average review time: 102 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

JFP devices are reviewed by the Chemistry panel. Browse all Chemistry devices →