510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K211342Substantially Equivalent

Sofia 2 Campylobacter FIA

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

K211342 is the FDA 510(k) clearance record for Sofia 2 Campylobacter FIA, a class I device, cleared for Quidel Corporation on under FDA product code LQP (Campylobacter Spp.). FDA records list 311 510(k) clearances for ORTHO-CLINICAL DIAGNOSTICS, INC., from to . As of , FDA records show no recalls naming K211342.

Clearance record

Decision date
Received
(204 days to decision)
Product code
LQP Campylobacter Spp.
Regulation
21 CFR 866.3110
Device class
Class I
Review panel
Microbiology
Applicant
Quidel Corporation 10165 Mckellar Ct., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LQP

Trailing 12 months

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

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