510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K042118Substantially Equivalent

Athena Multi-Lyte Ebv Igg Test System

Zeus Scientific LLC, Branchburg NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K042118 is the FDA 510(k) clearance record for ATHENA MULTI-LYTE EBV IGG TEST SYSTEM, a class I device, cleared for Zeus Scientific, Inc. on under FDA product code JRY (Antiserum, Fluorescent, Epstein-Barr Virus). FDA records list 141 510(k) clearances for Zeus Scientific, Inc., from to . As of , FDA records show no recalls naming K042118.

Clearance record

Decision date
Received
(266 days to decision)
Product code
JRY Antiserum, Fluorescent, Epstein-Barr Virus
Regulation
21 CFR 866.3235
Device class
Class I
Review panel
Microbiology
Applicant
Zeus Scientific, Inc. 200 Evans Way, Branchburg NJ
510(k) summary
Statement
Third party review
No

Clearances, product code JRY

Trailing 12 months

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

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