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510(k) K243496

Device
MycoMEIA Aspergillus Assay
Applicant
Pearl Diagnostics, Inc.
510(k) number
K243496
Product code
NOM
Decision
Substantially Equivalent (SESE)
Decision date
2025-08-01
Date received
2024-11-12
Regulation
866.3040
Classification name
Antigen, Galactomannan, Aspergillus Spp.
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Irina Baburina
Address
1812 Ashland Ave. Suite G32 Baltimore MD US 21205 21205

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NOM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K093678PLATELIA ASPERGILLUS EIA MODEL 62793Bio-Rad2011-01-13
K060641PLATELIA ASPERGILLUS EIA, MODEL 62793Bio-Rad2006-06-02
K023857PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794Bio-Rad2003-05-16