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510(k) K220272

Device
cobas pulse blood glucose monitoring system
Applicant
Roche Diagnostics
510(k) number
K220272
Product code
PZI
Decision
Substantially Equivalent (SESE)
Decision date
2024-04-26
Date received
2022-01-31
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
Teresa Carrow
Address
9115 Hague Rd. Indianapolis IN US 46250 46250

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PZI#

510(k), Device, Applicant table
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K221349XPER Technology PREMIUM Pro Blood Glucose Monitoring SystemTaidoc Technology Corporation2024-11-19
K232075StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation2024-02-23
K200788Assure Titanium Blood Glucose Monitoring SystemArkray, Inc.2022-05-23
K182549StatStrip Xpress 2 Glucose Hospital Meter SystemNova Biomedical Corporation2018-12-13
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