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510(k) K230300

Device
i-STAT CG8+ cartridge with the i-STAT 1 System
Applicant
Abbott Point of Care, Inc.
510(k) number
K230300
Product code
JFP
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-27
Date received
2023-02-03
Regulation
862.1145
Classification name
Electrode, Ion Specific, Calcium
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Brian Ma
Address
400 College Rd. E. Princton NJ US 08540 08540

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JFP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K191360i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2020-02-14
K191626Stat Profile Prime ES Comp Plus Analyzer SystemNova Biomedical Corporation2019-08-16
K152327EasyLyte Na/K/Cl/Ca AnalyzerMedica Corporation2016-12-01
K984299AVL OPTI CRITICAL CARE ANALYZERAvl Scientific Corp.1998-12-11
K972673AVL 9181 ELECTROLYTE ANALYZERAvl Scientific Corp.1997-08-20
K963694EASYLYTE CALCIUM/CHLORIDE ANALYZERMedica Corp.1996-11-27
K961458AVL 9180 ELECTROLYTE ANALYZERAvl Scientific Corp.1996-06-12
K960120STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERSNova Biomedical Corp.1996-03-11
K943091EASY LYTE CALCIUM ANALYZERMedica Corp.1995-01-17
K943702AVL 988-4 ELECTROLYTE ANALYZERAvl Scientific Corp.1994-09-09
K934642I-STAT IONIZED CALCIUM TESTI-Stat Corp.1993-12-17
K915675ELECTRODE, ION SPECIFICAlko Diagnostic Corp.1992-04-29
K904726LYTENING TM 6/RAmdev, Inc.1990-12-18
K896316EOS IONIZED CALCIUM TEST CARDEos Technology Corp.1990-02-13
K895397CALCIUM AND PH ELECTROLYTE ANALYZERIonetics, Inc.1989-12-12