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510(k) K203790

Device
GEM Premier 5000
Applicant
Instrumentation Laboratory Co.
510(k) number
K203790
Product code
CHL  
Decision
Substantially Equivalent (SESE)
Decision date
2021-08-20
Date received
2020-12-28
Regulation
862.1120
Classification name
Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Gabriella Erdosy
Address
180 Hartwell Rd. Bedford MA US 01730 01730

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CHL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252207ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals Aps2026-04-10
K244014i-STAT CG4+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2025-05-02
K240998ABL90 FLEX PLUS SystemRadiometer Medicals Aps2024-12-13
K230285i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2023-10-27
K221900Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation2023-09-29
K223857i-STAT G3+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2023-09-15
K223608GEM Premier 7000 with IQM3Instrumentation Laboratory Company2023-08-10
K211559EasyStat 300Medica Corporation2023-01-27
K200986OPTI® B-Lac CassetteOpti Medical Systems, Inc.2021-08-02
K200107epoc Blood Analysis SystemEpocal, Inc.2020-06-05
K200492i-STAT CG4+ Cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2020-04-09
K192240RAPIDPoint 500e Blood Gas SystemSiemens Healthcare Diagnostics, Inc.2020-03-27
K193246Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation2020-01-24
K173797Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation2018-07-17
K173403GEM Premier 5000Instrumentation Laboratory CO2017-12-29

Legacy Summary#

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FDA Review#

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