510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K882447Substantially Equivalent

Epstein-Barr Virus Early Antigen (Ea) Antibody Tes

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

K882447 is the FDA 510(k) clearance record for EPSTEIN-BARR VIRUS EARLY ANTIGEN (EA) ANTIBODY TES, a class I device, cleared for Zeus Scientific, Inc. on under FDA product code LSE (Epstein-Barr Virus, Other). FDA records list 141 510(k) clearances for Zeus Scientific, Inc., from to . As of , FDA records show no recalls naming K882447.

Clearance record

Decision date
Received
(184 days to decision)
Product code
LSE Epstein-Barr Virus, Other
Regulation
21 CFR 866.3235
Device class
Class I
Review panel
Microbiology
Applicant
Zeus Scientific, Inc. P.O.Box 38, Raritan NJ
Third party review
No

Clearances, product code LSE

Trailing 12 months
2 clearances under product code LSE in the twelve months to October 2026, October 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LSE, 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 20262