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510(k) K231465

Device
Q-Pad Test System
Applicant
Qurasense
510(k) number
K231465
Product code
LCP
Decision
Substantially Equivalent (SESE)
Decision date
2023-12-06
Date received
2023-05-19
Regulation
864.7470
Classification name
Assay, Glycosylated Hemoglobin
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sara Naseri
Address
3517 Edison Way, Suite D Menlo Park CA US 94025 94025

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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