510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243496Substantially Equivalent

MycoMEIA Aspergillus Assay

Pearl Diagnostics, Inc., Baltimore MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243496 is the FDA 510(k) clearance record for MycoMEIA Aspergillus Assay, a class I device, cleared for Pearl Diagnostics, Inc. on under FDA product code NOM (Antigen, Galactomannan, Aspergillus Spp.). FDA's definition for product code NOM reads: "The Platelia Aspergillus EIA is an immunoenzymatic sandwich microplate assay for the detection of Aspergillus galactomannan antigen in human serum. It is a test which, when used in conjunction with other diagnostic procedures such as...". FDA records list one 510(k) clearance for Pearl Diagnostics, Inc. As of , FDA records show no recalls naming K243496.

Clearance record

Decision date
Received
(262 days to decision)
Product code
NOM Antigen, Galactomannan, Aspergillus Spp.
Regulation
21 CFR 866.3040
Device class
Class I
Review panel
Microbiology
Applicant
Pearl Diagnostics, Inc. 1812 Ashland Ave., Baltimore MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NOM

Trailing 12 months

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

FDA records show no clearances under product code NOM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NOM, 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