FDA.reportPublic FDA data

Andersen Sterilizers, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30046347103004634710Andersen Sterilizers, Inc.1N2026-01-013154 Caroline Dr Haw River NC US 27258

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1930241439595263K213296Anprolene SteriTest RRBIFRC2022-04-12
1930241516437180K202879EOGas 4 Endo-SteriTest RRBIFRC2021-03-03
1930241245147143K200336Tyvek Sterilization Pouches with Chevron SealFRG2020-11-12
1930241668824846K200335Sterisheet Sterilization WrapFRG2020-11-12
1930241608618442K200334AN1036 DosimeterJOJ2020-11-12
1930241832005811K192980EOGas 4 Endo-SteriTestFRC2020-11-12
1930241525048982K192978EOGas 4 Ethylene Oxide Gas SterilizerFLF2020-11-12
1930242024658888K170439AN87 DosimeterJOJ2017-11-01
1930241782304850K170437Sterisheet Sterilization WrapFRG2017-11-01
1930241550233228K170432Anprolene AN75 Ethylene Oxide Gas SterilizerFLF2017-10-31
1930241925484050K170429Tyvek Sterilization Pouches with Chevron SealFRG2017-10-27
1930241535469380K170427Anprolene SteriTestFRC2017-10-31
1930241364931061K170426AN85/AN86 EO IndicatorsJOJ2017-10-30
1930241239963268K152291Sterisheet Sterilization WrapFRG2015-12-17
1930241883709394K152058Tyvek Sterilization Pouches with Chevron SealFRG2015-11-18
1930241100373118K151585Andersen EOGas 4 SteriTestFRC2015-11-18
1930241307639054K150646EOGas 4 Ethylene Oxide Gas SterilizerFLF2015-11-18
1930241363724715K150645AN1087 DosimeterJOJ2015-11-19
1930241832070055K150644AN85/AN86 EO IndicatorsJOJ2015-11-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FRG62020-11-12
FRC52022-04-12
JOJ52020-11-12
FLF32020-11-12

PMN#