510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K992191Substantially Equivalent

Eti-Ea-G Assay

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

K992191 is the FDA 510(k) clearance record for ETI-EA-G ASSAY, a class I device, cleared for DiaSorin, Inc. on under FDA product code LSE (Epstein-Barr Virus, Other). FDA records list 74 510(k) clearances for DiaSorin, Inc., from to . As of , FDA records show one recall naming K992191.

Clearance record

Decision date
Received
(14 days to decision)
Product code
LSE Epstein-Barr Virus, Other
Regulation
21 CFR 866.3235
Device class
Class I
Review panel
Microbiology
Applicant
DiaSorin, Inc. 9175 Guiford Rd., Columbia MD
510(k) summary
Summary
Third party review
Yes

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