510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K922331Substantially Equivalent

Bartels Epstein-Barr Virus Igm Eia

Baxter Diagnostics, Inc., Bellevue WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922331 is the FDA 510(k) clearance record for BARTELS EPSTEIN-BARR VIRUS IGM EIA, a class I device, cleared for Baxter Diagnostics, Inc. on under FDA product code LJN (Antibody Igm, If, Epstein-Barr Virus). FDA records list 72 510(k) clearances for Baxter Diagnostics, Inc., from to . As of , FDA records show no recalls naming K922331.

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
Baxter Diagnostics, Inc. Bartels Diagnostics Division, Bellevue WA
510(k) summary
Summary
Third party review
No

Clearances, product code LJN

Trailing 12 months

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

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