510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K833014Substantially Equivalent

Ebv-Vca-Igm Ifa Test System

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

K833014 is the FDA 510(k) clearance record for EBV-VCA-IGM IFA TEST SYSTEM, a class I device, cleared for Zeus Scientific, Inc. on under FDA product code LJN (Antibody Igm, If, Epstein-Barr Virus). FDA records list 141 510(k) clearances for Zeus Scientific, Inc., from to . As of , FDA records show no recalls naming K833014.

Clearance record

Decision date
Received
(112 days to decision)
Product code
LJN Antibody Igm, If, Epstein-Barr Virus
Regulation
21 CFR 866.3235
Device class
Class I
Review panel
Microbiology
Applicant
Zeus Scientific, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LJN

Trailing 12 months
1 clearance under product code LJN in the twelve months to October 2026, October 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LJN, 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 20261