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Company-Registration
1312520637
Device Listing 1312520637
Listing Summary
#
Listing key
1312520637
Premarket submission
K260184
Device
Onclarity™ Self-Collection Kit
Applicant
Becton, Dickinson and Company
Product code
SEP
Decision date
2026-04-02
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
227758
3015209536
3015209536
Privapath Diagnostics Ltd
1
N
2026-01-01
Unit 1, Northern Cross Business Park North Road Dublin 11 Dublin(County) IE D11 XT26
297642
3020139194
3020139194
LetsGetChecked Inc.
1
N
2026-01-01
10825 7th Street, Suite A Cucamonga CA US 91730
346799
3042854290
3042854290
LetsGetChecked Inc
1
Y
2026-01-01
Suite 300, 8407 Firebird Dr, Fairfield, OH 45011, USA City View Heights OH US 45011