Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1100067635
Device Listing 1100067635
Listing Summary
#
Listing key
1100067635
Premarket submission
K243496
Device
MycoMEIA Aspergillus Assay
Applicant
Pearl Diagnostics, Inc.
Product code
NOM
Decision date
2025-08-01
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
311090
3022929618
3022929618
PEARL DIAGNOSTICS, INC.
1
N
2026-01-01
1812 Ashland Ave Ste G32 Baltimore MD US 21205