510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K925690Substantially Equivalent

Meridian Ebna Test Kit

Fuller Laboratories, Inc., Fullerton CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K925690 is the FDA 510(k) clearance record for MERIDIAN EBNA TEST KIT, a class I device, cleared for Fuller Laboratories, Inc. on under FDA product code LLM (Test, Antigen, Nuclear, Epstein-Barr Virus). FDA records list 4 510(k) clearances for Fuller Laboratories, Inc., from to . As of , FDA records show no recalls naming K925690.

Clearance record

Decision date
Received
(334 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
Fuller Laboratories, Inc. 2478 E. Fender, Unit 1, Fullerton CA
510(k) summary
Statement
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