510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911569Substantially Equivalent

Epstein-Barr Virus Ebna-Igg Antibody Elisa Test

Ortho Diagnostic Systems, Inc., Carpinteria CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911569 is the FDA 510(k) clearance record for EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST, a class I device, cleared for Ortho Diagnostic Systems, Inc. on under FDA product code LLM (Test, Antigen, Nuclear, Epstein-Barr Virus). FDA records list 126 510(k) clearances for Ortho Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K911569.

Clearance record

Decision date
Received
(63 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
Ortho Diagnostic Systems, Inc. 1125 Mark Ave., Carpinteria CA
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