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Company-Registration
1782890459
Device Listing 1782890459
Listing Summary
#
Listing key
1782890459
Premarket submission
K260160
Device
VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
Applicant
bioMerieux, Inc.
Product code
SAN
Decision date
2026-07-08
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
9759
1950204
1950204
BIOMERIEUX, INC.
1
Y
2026-01-01
595 ANGLUM RD. HAZELWOOD MO US 63042
309859
3023036790
3023036790
Specific Diagnostics
1
N
2026-01-01
130 Baytech Dr San Jose CA US 95134