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510(k) K182549

Device
StatStrip Xpress 2 Glucose Hospital Meter System
Applicant
Nova Biomedical Corporation
510(k) number
K182549
Product code
PZI  
Decision
Substantially Equivalent (SESE)
Decision date
2018-12-13
Date received
2018-09-17
Regulation
862.1345
Classification name
Prescription Use Blood Glucose Meter For Near-patient Testing
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Dual Track
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Khushboo Surendran
Address
200 Prospect St. Walham MA US 02454 02454

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PZI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K221349XPER Technology PREMIUM Pro Blood Glucose Monitoring SystemTaidoc Technology Corporation2024-11-19
K220272cobas pulse blood glucose monitoring systemRoche Diagnostics2024-04-26
K232075StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation2024-02-23
K200788Assure Titanium Blood Glucose Monitoring SystemArkray, Inc.2022-05-23
K182552StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation2018-12-13
K181043StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation2018-07-12
K163490StatStrip Xpress 2 Glucose Hospital Meter SystemNova Biomedical Corporation2017-01-06
K161856StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation2016-11-15
K152986StatStrip Xpress 2 Glucose Hospital Meter SystemNova Biomedical Corporation2016-01-27
K150461StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation2015-05-20
K150281StatStrip Glucose Hospital MeterNova Biomedical Corporation2015-05-06
K132121STATSTRIP GLUCOSE HOSPITAL METER SYSTEMNova Biomedical Corporation2014-09-24

Legacy Summary#

summary

FDA Review#

Decision Summary