510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K131606Substantially Equivalent

Sofia Influenza A+b Fia

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

K131606 is the FDA 510(k) clearance record for SOFIA INFLUENZA A+B FIA, a class I device, cleared for Quidel Corp. on under FDA product code GNX (Antigens, Cf (Including Cf Control), Influenza Virus A, B, C). FDA records list 311 510(k) clearances for ORTHO-CLINICAL DIAGNOSTICS, INC., from to . As of , FDA records show no recalls naming K131606.

Clearance record

Decision date
Received
(32 days to decision)
Product code
GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Regulation
21 CFR 866.3330
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 GNX

Trailing 12 months

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

FDA records show no clearances under product code GNX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GNX, 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