FDA Product Code JFP: Electrode, Ion Specific, Calcium
Leading manufacturers include Nova Biomedical Corp., Abbott Point of Care, Inc. and Medica Corp..
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
Cleared
Oct 27, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
Chemistry
266d
Cleared
Feb 14, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
Chemistry
269d
Cleared
Aug 16, 2019
Stat Profile Prime ES Comp Plus Analyzer System
Nova Biomedical Corporation
Chemistry
59d
Cleared
Nov 27, 1996
EASYLYTE CALCIUM/CHLORIDE ANALYZER
Medica Corp.
Chemistry
72d
Cleared
Mar 11, 1996
STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS
Nova Biomedical Corp.
Chemistry
60d
Cleared
Jan 17, 1995
EASY LYTE CALCIUM ANALYZER
Medica Corp.
Chemistry
203d
Cleared
Feb 10, 1989
IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY
Instrumentation Laboratory CO
Chemistry
88d
Cleared
Feb 04, 1985
CORNING CALCIUM PH ANALYZER 634
Corning Medical & Scientific
Chemistry
101d
Cleared
Apr 05, 1983
NOVA 7 TOTAL CALCIUM/IONIZED CALCIUM
Nova Biomedical Corp.
Chemistry
71d
Cleared
Mar 24, 1983
NOVA 8 IONIZED CALCIUM/PH ANALYZER
Nova Biomedical Corp.
Chemistry
36d
Cleared
Feb 02, 1983
SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ
Nova Biomedical Corp.
Chemistry
79d
Cleared
Sep 28, 1977
NOVA 2 IONIZED CALCIUM ANALYZER
Nova Biomedical Corp.
Chemistry
30d
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.