FDA.reportPublic FDA data

Invivoscribe, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30141730603014173060Invivoscribe, Inc.1N2026-01-0110222 Barnes Canyon Road, Building 1 San Diego CA US 92121

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2142181340000896P160040LeukoStrat CDx FLT3 Mutation AssayOWD2017-04-28
2142181285296458
2142181704638894

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OWD12017-04-28

PMA#

LeukoStrat CDx FLT3 Mutation Assay

2022-04-11

INVIVOSCRIBE TECHNOLOGIES, INC10222 Barnes Canyon Road, Building 1san Diego, CA 92121 PMA NumberP160040 Supplement NumberS010 Date Received03/15/2022 Decision Date04/11/2022 Product Code OWD  Advisory Committee Pathology Supplement Type30-day Notice Supplem...

GUDID#

94 records. Showing 1-40. Next