510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K231795Substantially Equivalent

QuickVue COVID-19 Test

Ortho-Clinical Diagnostics, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231795 is the FDA 510(k) clearance record for QuickVue COVID-19 Test, a class II device, cleared for Quidel Corporation on under FDA product code QYT (Over-The-Counter Covid-19 Antigen Test). FDA's definition for product code QYT reads: "For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older". FDA records list 311 510(k) clearances for ORTHO-CLINICAL DIAGNOSTICS, INC., from to . As of , FDA records show no recalls naming K231795.

Clearance record

Decision date
Received
(276 days to decision)
Product code
QYT Over-The-Counter Covid-19 Antigen Test
Regulation
21 CFR 866.3984
Device class
Class II
Review panel
Microbiology
Applicant
Quidel Corporation 10165 Mckellar Ct., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QYT

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