510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K123355Substantially Equivalent

Amplivue C. Difficile Assay

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

K123355 is the FDA 510(k) clearance record for AMPLIVUE C. DIFFICILE ASSAY, a class II device, cleared for Quidel Corporation on under FDA product code OZN (C. Difficile Toxin Gene Amplification Assay). FDA's definition for product code OZN reads: "Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients". FDA records list 311 510(k) clearances for ORTHO-CLINICAL DIAGNOSTICS, INC., from to . As of , FDA records show no recalls naming K123355.

Clearance record

Decision date
Received
(43 days to decision)
Product code
OZN C. Difficile Toxin Gene Amplification Assay
Regulation
21 CFR 866.3130
Device class
Class II
Review panel
Microbiology
Applicant
Quidel Corporation 10165 Mckellar Ct., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OZN

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