510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K070747Substantially Equivalent

Quick Vue Rsv Test, Models 20193, 20199

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

K070747 is the FDA 510(k) clearance record for QUICK VUE RSV TEST, MODELS 20193, 20199, a class I device, cleared for Quidel Corp. on under FDA product code GQG (Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus). FDA records list 311 510(k) clearances for ORTHO-CLINICAL DIAGNOSTICS, INC., from to . As of , FDA records show no recalls naming K070747.

Clearance record

Decision date
Received
(35 days to decision)
Product code
GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
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 GQG

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