FDA.reportPublic FDA data

COLOR DIAGNOSTICS, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30118452253011845225COLOR DIAGNOSTICS, LLC1N2026-01-01365 Oyster Point Blvd Suite 300-3A South San Francisco CA US 94080

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3098861352445822K260184Onclarity™ Self-Collection KitSEP2026-04-02
3098861745267696K221131Tasso+FMK2022-08-12
3098861609439673K191147OC-Auto SENSOR io iFOB TestOOX2020-01-02
3098861117337778K152556Oragene DxOYJ2016-05-26
3098861204535612

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
SEP12026-04-02
FMK12022-08-12
OOX12020-01-02
OYJ12016-05-26

GUDID#