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510(k) K230275

Device
i-STAT CG8+ cartridge with the i-STAT 1 System
Applicant
Abbott Point of Care, Inc.
510(k) number
K230275
Product code
JGS
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-27
Date received
2023-02-01
Regulation
862.1665
Classification name
Electrode, Ion Specific, Sodium
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 JGS#

510(k), Device, Applicant table
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K183549GEM Premier ChemSTATInstrumentation Laboratory CO2019-02-16
K180428Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation2018-08-15
K181201Synermed ISE ReagentsInfrared Laboratory Systems, LLC (Dba Synermed)2018-07-10
K171476SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)Awareness Technology, Inc.2018-02-27
K161954Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)Siemens Healthcare Diagnostics2017-03-09
K161837ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry AnalyzerBeckman Coulter, Inc.2016-12-16
K160225GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit EvaluatorInstrumentation Laboratory CO2016-12-14