FDA.report

BIOGENNIX, LLC

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30087735603008773560BIOGENNIX, LLC1N2026-01-0118009 Sky Park Cir Ste K Irvine CA US 92614

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1092361639791300K193487Agilon StripMQV2020-03-30
1092361161165147K193168Agilon MoldableMQV2020-02-13
1092361127860291K190371Morpheus-CMQV2019-08-09
1092361425829041K190177J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,KNW2019-06-12
1092361051251672K142828osteoSPAN MorpheusMQV2015-01-15
1092361989033066K141798SYPHER SPACER SYSTEMOVD2015-02-19
1092361510600834K093342BIOGENNIX RPCMQV2010-07-29
1092361028843089
1092361031362063
1092361032181720
1092361182531450
1092361370060582
1092361438369249
1092361546694823
1092361787891372
1092361931920800
1092362012236580

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
MQV52020-03-30
KNW12019-06-12
OVD12015-02-19

PMN

GUDID

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