FDA.report

510(k) K230878

Device
QScout Lab; QScout RLD
Applicant
Ad Astra Diagnostics, Inc.
510(k) number
K230878
Product code
GKZ
Decision
Substantially Equivalent (SESE)
Decision date
2023-11-14
Date received
2023-03-30
Regulation
864.5220
Classification name
Counter, Differential Cell
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Jasper Pollard
Address
633 Davis Dr. Suite 460 Morrisville NC US 27560 27560

FDA Registration Numbers

Source Documents

510(k) summary PDF

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