Atlas FDA

JFP

29 FDA 510(k) clearances · Product code

77 daysmedian time to decision
266 days90th percentile
29clearances measured

FDA profile

Official device name
Electrode, Ion Specific, Calcium
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1145
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
Adverse events (MAUDE)
1994: 1 · 2001: 1 · 2008: 5 · 2009: 5 · 2011: 8 · 2025: 41
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
i-STAT CG8+ cartridge with the i-STAT 1 System (K230300)Abbott Point of Care, Inc.2023-10-27
i-STAT CHEM8+ cartridge with the i-STAT 1 System (K191360)Abbott Point of Care, Inc.2020-02-14
Stat Profile Prime ES Comp Plus Analyzer System (K191626)Nova Biomedical Corporation2019-08-16
EasyLyte Na/K/Cl/Ca Analyzer (K152327)Medica Corporation2016-12-01
AVL OPTI CRITICAL CARE ANALYZER (K984299)Avl Scientific Corp.1998-12-11
AVL 9181 ELECTROLYTE ANALYZER (K972673)Avl Scientific Corp.1997-08-20
EASYLYTE CALCIUM/CHLORIDE ANALYZER (K963694)Medica Corp.1996-11-27
AVL 9180 ELECTROLYTE ANALYZER (K961458)Avl Scientific Corp.1996-06-12
STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS (K960120)Nova Biomedical Corp.1996-03-11
EASY LYTE CALCIUM ANALYZER (K943091)Medica Corp.1995-01-17
AVL 988-4 ELECTROLYTE ANALYZER (K943702)Avl Scientific Corp.1994-09-09
I-STAT IONIZED CALCIUM TEST (K934642)I-Stat Corp.1993-12-17
ELECTRODE, ION SPECIFIC (K915675)Alko Diagnostic Corp.1992-04-29
LYTENING TM 6/R (K904726)Amdev, Inc.1990-12-18
EOS IONIZED CALCIUM TEST CARD (K896316)Eos Technology Corp.1990-02-13
CALCIUM AND PH ELECTROLYTE ANALYZER (K895397)Ionetics, Inc.1989-12-12
IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY (K884771)Instrumentation Laboratory CO1989-02-10
LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ (K884731)Amdev, Inc.1989-02-03
MICROLYTE 7 (K880973)The Rupp & Bowman Co.1988-09-07
'MICROLYTE 4/5' (K873345)Kone Instruments, Inc.1987-09-11
IONIZED CALCIUM AND BLOOD PH TESTCARDS (K860639)Ilex Corp.1986-04-21
CORNING CALCIUM PH ANALYZER 634 (K844188)Corning Medical & Scientific1985-02-04
NOVA 7 TOTAL CALCIUM/IONIZED CALCIUM (K830213)Nova Biomedical Corp.1983-04-05
NOVA 8 IONIZED CALCIUM/PH ANALYZER (K830502)Nova Biomedical Corp.1983-03-24
SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ (K823389)Nova Biomedical Corp.1983-02-02
MODEL AM 722 (K810203)Applied Medical Technologies1981-02-10
MINIATURE ION SELECTIVE ELECTRODES (K802856)Ionetics, Inc.1981-01-28
ICA1 IONIZED CALCIUM ANALYZER (K801848)The London Co.1980-10-31
NOVA 2 IONIZED CALCIUM ANALYZER (K771643)Nova Biomedical Corp.1977-09-28

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Every clearance here is in the API, with alerts when new ones post.