JFP · Class II · 21 CFR 862.1145

FDA Product Code JFP: Electrode, Ion Specific, Calcium

Leading manufacturers include Nova Biomedical Corp., Avl Scientific Corp. and Amdev, 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
Cleared Feb 14, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K191360
Abbott Point of Care, Inc.
Chemistry · 269d
Cleared Aug 16, 2019
Stat Profile Prime ES Comp Plus Analyzer System
K191626
Nova Biomedical Corporation
Chemistry · 59d
Cleared Dec 01, 2016
EasyLyte Na/K/Cl/Ca Analyzer
K152327
Medica Corporation
Chemistry · 471d
Cleared Dec 11, 1998
AVL OPTI CRITICAL CARE ANALYZER
K984299
Avl Scientific Corp.
Chemistry · 10d
Cleared Aug 20, 1997
AVL 9181 ELECTROLYTE ANALYZER
K972673
Avl Scientific Corp.
Chemistry · 35d
Cleared Nov 27, 1996
EASYLYTE CALCIUM/CHLORIDE ANALYZER
K963694
Medica Corp.
Chemistry · 72d
Cleared Jun 12, 1996
AVL 9180 ELECTROLYTE ANALYZER
K961458
Avl Scientific Corp.
Chemistry · 58d
Cleared Mar 11, 1996
STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS
K960120
Nova Biomedical Corp.
Chemistry · 60d
Cleared Jan 17, 1995
EASY LYTE CALCIUM ANALYZER
K943091
Medica Corp.
Chemistry · 203d
Cleared Sep 09, 1994
AVL 988-4 ELECTROLYTE ANALYZER
K943702
Avl Scientific Corp.
Chemistry · 42d
Cleared Dec 17, 1993
I-STAT IONIZED CALCIUM TEST
K934642
I-Stat Corp.
Chemistry · 87d
Cleared Apr 29, 1992
ELECTRODE, ION SPECIFIC
K915675
Alko Diagnostic Corp.
Chemistry · 132d
Cleared Dec 18, 1990
LYTENING TM 6/R
K904726
Amdev, Inc.
Chemistry · 62d
Cleared Feb 13, 1990
EOS IONIZED CALCIUM TEST CARD
K896316
Eos Technology Corp.
Chemistry · 104d
Cleared Dec 12, 1989
CALCIUM AND PH ELECTROLYTE ANALYZER
K895397
Ionetics, Inc.
Chemistry · 102d
Cleared Feb 10, 1989
IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY
K884771
Instrumentation Laboratory CO
Chemistry · 88d
Cleared Feb 03, 1989
LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ
K884731
Amdev, Inc.
Chemistry · 85d
Cleared Sep 07, 1988
MICROLYTE 7
K880973
The Rupp & Bowman Co.
Chemistry · 183d
Cleared Sep 11, 1987
'MICROLYTE 4/5'
K873345
Kone Instruments, Inc.
Chemistry · 23d
Cleared Apr 21, 1986
IONIZED CALCIUM AND BLOOD PH TESTCARDS
K860639
Ilex Corp.
Chemistry · 60d
Cleared Feb 04, 1985
CORNING CALCIUM PH ANALYZER 634
K844188
Corning Medical & Scientific
Chemistry · 101d
Cleared Apr 05, 1983
NOVA 7 TOTAL CALCIUM/IONIZED CALCIUM
K830213
Nova Biomedical Corp.
Chemistry · 71d
Cleared Mar 24, 1983
NOVA 8 IONIZED CALCIUM/PH ANALYZER
K830502
Nova Biomedical Corp.
Chemistry · 36d

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.