510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K946353Substantially Equivalent

Epstein-Barr Virus Nuclear Antigen Recombinant Immunofluorescent Assay

Mrl Diagnostics, Cypress CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K946353 is the FDA 510(k) clearance record for EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY, a class I device, cleared for Mrl Diagnostics on under FDA product code LLM (Test, Antigen, Nuclear, Epstein-Barr Virus). FDA records list 7 510(k) clearances for Mrl Diagnostics, from to . As of , FDA records show no recalls naming K946353.

Clearance record

Decision date
Received
(203 days to decision)
Product code
LLM Test, Antigen, Nuclear, Epstein-Barr Virus
Regulation
21 CFR 866.3235
Device class
Class I
Review panel
Microbiology
Applicant
Mrl Diagnostics 10703 Progress Way, Cypress CA
510(k) summary
Summary
Third party review
No

Clearances, product code LLM

Trailing 12 months

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

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