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510(k) K950628

Device
FIRST CHOICE TEST STRIP
Applicant
POLYMER TECHNOLOGY INTL.
510(k) number
K950628
Product code
CGA  
Decision
Substantially Equivalent (SESE)
Decision date
1995-11-08
Date received
1995-02-13
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
ROB NGUNGU
Address
1871 NW Gilman Blvd. Issaquah WA US 98027 98027

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CGA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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#

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FDA Review#

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