510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K893737Substantially Equivalent

Directigen 1-2-3 Infectious Mononucleosis Test

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

K893737 is the FDA 510(k) clearance record for DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST, a class II device, cleared for Quidel Corp. on under FDA product code KTN (System, Test, Infectious Mononucleosis). FDA records list 311 510(k) clearances for ORTHO-CLINICAL DIAGNOSTICS, INC., from to . As of , FDA records show no recalls naming K893737.

Clearance record

Decision date
Received
(30 days to decision)
Product code
KTN System, Test, Infectious Mononucleosis
Regulation
21 CFR 866.5640
Device class
Class II
Review panel
Immunology
Applicant
Quidel Corp. 10165 Mckellar Ct., San Diego CA
Third party review
No

Clearances, product code KTN

Trailing 12 months

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

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