FDA.reportPublic FDA data

510(k) K960855

Device
PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH AND LOW GLUCOSE CONTROL
Applicant
HOME DIAGNOSTICS, INC.
510(k) number
K960855
Product code
CGA  
Decision
Substantially Equivalent (SESE)
Decision date
1996-11-07
Date received
1996-03-01
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
VIK BAJNATH
Address
2600 NW 55th Ct. Suite #239 Ft Lauderdale FL US 33309 33309

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#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases