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510(k) K213486

Device
GLP Systems Track
Applicant
Abbott Laboratories
510(k) number
K213486
Product code
JGS  
Decision
Substantially Equivalent (SESE)
Decision date
2022-03-10
Date received
2021-10-29
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
Michele Smith Waheed
Address
100 Abbott Park Rd. Abbott Park IL US 60064 60064

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JGS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252475ABL90 FLEX PLUS SystemRadiometer Medicals Aps2026-05-01
K230275i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2023-10-27
K222438A-LYTE® Integrated Multisensor (IMT Na K Cl)Siemens Healthcare Diagnostics, Inc.2023-07-25
K220977ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerBeckman Coulter Laboratory Systems (Suzhou) Co., Ltd.2023-07-20
K200403Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation2020-04-14
K183688i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2020-02-07
K191365Stat Profile Prime ES Comp Plus Analyzer SystemNova Biomedical Corporation2019-07-19
K172232LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600Ams Diagnostics2019-06-12
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

Legacy Summary#

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FDA Review#

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