510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911362Substantially Equivalent

Amizyme Epstein-Barr Virus (Ebv) Igm Antibody Test

Amico Laboratories, Inc., Nashville TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911362 is the FDA 510(k) clearance record for AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST, a class I device, cleared for Amico Laboratories, Inc. on under FDA product code LJN (Antibody Igm, If, Epstein-Barr Virus). FDA records list one 510(k) clearance for Amico Laboratories, Inc. As of , FDA records show no recalls naming K911362.

Clearance record

Decision date
Received
(193 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
Amico Laboratories, Inc. P.O. Box 90203, Nashville TN
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