510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162911Substantially Equivalent

Sofia RSV FIA on Sofia 2 analyzer

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

K162911 is the FDA 510(k) clearance record for Sofia RSV FIA on Sofia 2 analyzer, a class I device, cleared for Quidel Corporation 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 one recall naming K162911.

Clearance record

Decision date
Received
(128 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 Corporation 12544 High Bluff Dr., Suite 200, 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 October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GQG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260