510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K992587Substantially Equivalent

Epstein-Barr Virus Early Antigen (Ebv-Ea) Igg Ifa Test System

Stellar Bio Systems, Inc., Columbia MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992587 is the FDA 510(k) clearance record for EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM, a class I device, cleared for Stellar Bio Systems, Inc. on under FDA product code LSE (Epstein-Barr Virus, Other). FDA records list 7 510(k) clearances for Stellar Bio Systems, Inc., from to . As of , FDA records show no recalls naming K992587.

Clearance record

Decision date
Received
(142 days to decision)
Product code
LSE Epstein-Barr Virus, Other
Regulation
21 CFR 866.3235
Device class
Class I
Review panel
Microbiology
Applicant
Stellar Bio Systems, Inc. 9075 Guilford Rd., Columbia MD
510(k) summary
Summary
Third party review
No

Clearances, product code LSE

Trailing 12 months

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

FDA records show no clearances under product code LSE in the twelve months to October 2026.
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 20260