510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K230878Substantially Equivalent

QScout Lab; QScout RLD

Ad Astra Diagnostics, Inc., Morrisville NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K230878 is the FDA 510(k) clearance record for QScout Lab; QScout RLD, a class II device, cleared for Ad Astra Diagnostics, Inc. on under FDA product code GKZ (Counter, Differential Cell). FDA records list one 510(k) clearance for Ad Astra Diagnostics, Inc. As of , FDA records show no recalls naming K230878.

Clearance record

Decision date
Received
(229 days to decision)
Product code
GKZ Counter, Differential Cell
Regulation
21 CFR 864.5220
Device class
Class II
Review panel
Hematology
Applicant
Ad Astra Diagnostics, Inc. 633 Davis Dr., Morrisville NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GKZ

Trailing 12 months
4 clearances under product code GKZ in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GKZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20261
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260