FDA.reportPublic FDA data

APPLIED LABORATORIES, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
18313011831301APPLIED LABORATORIES, INC.1N2026-01-013240 N. Indianapolis Rd. COLUMBUS IN US 47201

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
40391250943400K183662Saline Wound Wash, SteriCleanse(TM)FRO2019-09-12
40391978516123K180764TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)NUC2018-08-01
40391845764709K161544Trojan Chain Reaction Personal LubricantNUC2016-08-31
40391039583838K141034AZUL PERSONAL LUBRICANTNUC2014-07-21
40392048419506K123427NIRVANA D PERSONAL LUBRICANT (TBD)NUC2013-06-28
40391226860801K120706NIRVANA A PERSONAL LUBRICANTNUC2012-10-04
40391685757246K103059TROPHONOUJ2011-02-24
40391516798405K083355WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553FRO2008-12-29
40391738137799
40391180307219
40391226860801
40391250943400
40391516798405
40391581615259
40391679919823
40391685757246
40391978516123
40392048419506

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NUC52018-08-01
FRO22019-09-12
OUJ12011-02-24

PMA#

PMN#