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
K061008Substantially Equivalent

Quickvue Rsv (20 Test Kit), Model 20193; (2 Test Kit), Model 20199

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

K061008 is the FDA 510(k) clearance record for QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199, a class I device, cleared for Quidel Corp. on under FDA product code MCE (Respiratory Syncytial Virus - Elisa). FDA records list 311 510(k) clearances for ORTHO-CLINICAL DIAGNOSTICS, INC., from to . As of , FDA records show no recalls naming K061008.

Clearance record

Decision date
Received
(149 days to decision)
Product code
MCE Respiratory Syncytial Virus - Elisa
Regulation
21 CFR 866.3480
Device class
Class I
Review panel
Microbiology
Applicant
Quidel Corp. 10165 Mckellar Ct., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MCE

Trailing 12 months

FDA records hold no clearances under product code MCE in the trailing twelve months.

FDA records show no clearances under product code MCE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MCE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260