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510(k) K041478

Device
BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR
Applicant
BECTON DICKINSON
510(k) number
K041478
Product code
CGA  
Decision
Substantially Equivalent (SESE)
Decision date
2004-10-28
Date received
2004-06-03
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
JOHN SCHALAGO
Address
1 Becton Dr. Franklin Lakes NJ US 07417 07417

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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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#

Decision Summary