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510(k) K022158

Device
IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT)
Applicant
INSTRUMENTATION LABORATORY CO.
510(k) number
K022158
Product code
CGA  
Decision
Substantially Equivalent (SESE)
Decision date
2002-09-10
Date received
2002-07-02
Regulation
862.1345
Classification name
Glucose Oxidase, Glucose
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
CAROL MARBLE
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 CGA  #

510(k), Device, Applicant table
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K252488ABL90 FLEX PLUS SystemRadiometer Medicals Aps2026-05-01
K210933YSI 2900C Biochemistry AnalyzerYsi, Inc.2024-09-30
K220328EasyStat 300Medica Corporation2024-07-26
K223179Cholestech LDX ™ SystemAlere San Diego, Inc.2023-09-20
K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2023-09-11
K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2023-07-28
K223090GEM Premier ChemSTATInstrumentation Laboratory CO2023-01-27
K203549Nova Primary Glucose Analyzer SystemNova Biomedical Corporation2022-10-18
K210958i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2021-08-13
K200349Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation2020-03-13
K183678i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2020-02-07
K190520VITROS XT Chemistry Products GLU-Ca SlidesOrtho-Clinical Diagnostics, Inc.2019-04-03
K183546GEM Premier ChemSTATInstrumentation Laboratory CO2019-02-16
K182781PTS Professional Chemistry KitPolymer Technology Systems, Inc. D/B/A Pts Diagnostics2018-12-21
K180340Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation2018-09-26

Legacy Summary#

summary

FDA Review#

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