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Panels › Clinical Chemistry › Product code PZI · Class 2

Prescription Use Blood Glucose Meter For Near-Patient Testing

Regulation 862.1345

1510(k)s in 12 months (14 all time)
5recalls in 12 months (6 all time)
3recalls that name a 510(k)
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Top companies in PZI

Company510(k)sRecalls
Nova Biomedical Corporation106
Roche Diagnostics20
Arkray, Inc.10
Taidoc Technology Corporation10
Decided510(k)Device and applicantCode
Jun 12, 2026K252323cobas pulse blood glucose monitoring system
Roche Diagnostics
PZI
Nov 19, 2024K221349XPER Technology PREMIUM Pro Blood Glucose Monitoring System
Taidoc Technology Corporation, TW
PZI
Apr 26, 2024K220272cobas pulse blood glucose monitoring system
Roche Diagnostics
PZI
Feb 23, 2024K232075StatStrip Glucose Hospital Meter System
Nova Biomedical Corporation
PZI
May 23, 2022K200788Assure Titanium Blood Glucose Monitoring System
Arkray, Inc., JP
PZI
Dec 13, 2018K182552StatStrip Xpress Glucose Hospital Meter System
Nova Biomedical Corporation
PZI
Dec 13, 2018K182549StatStrip Xpress 2 Glucose Hospital Meter System
Nova Biomedical Corporation
PZI
Jul 12, 2018K181043StatStrip Glucose Hospital Meter System
Nova Biomedical Corporation
PZI
Jan 6, 2017K163490StatStrip Xpress 2 Glucose Hospital Meter System
Nova Biomedical Corporation
PZI
Nov 15, 2016K161856StatStrip Xpress Glucose Hospital Meter System
Nova Biomedical Corporation
PZI
Jan 27, 2016K152986StatStrip Xpress 2 Glucose Hospital Meter System
Nova Biomedical Corporation
PZI
May 20, 2015K150461StatStrip Xpress Glucose Hospital Meter System
Nova Biomedical Corporation
PZI
May 6, 2015K150281StatStrip Glucose Hospital Meter
Nova Biomedical Corporation
PZI
Sep 24, 2014K132121STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
Nova Biomedical Corporation
PZI

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