FDA.reportPublic FDA data

Brian Frazier

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96105293002806560Brian Frazier1N2027-01-019115 Hague Rd Indianapolis IN US 46256
30036184813003618481Brian Frazier1N2027-01-019115 Hague Rd Indianapolis IN US 46256
10003694871000369487Brian Frazier1N2026-01-019115 Hague Rd Indianapolis IN US 46256
10004143421000414342Brian Frazier1N2026-01-019115 Hague Rd Indianapolis IN US 46256
30028533273002853327Brian Frazier1N2026-01-019115 Hague Rd Indianapolis IN US 46256
30050604463005060446Brian Frazier1N2026-01-019115 Hague Rd Indianapolis IN US 46256
30114408883011440888Brian Frazier1N2026-01-019115 Hague Rd Indianapolis IN US 46256
30134969583013496958Brian Frazier1N2026-01-019115 Hague Rd Indianapolis IN US 46256

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2020381328295118P110020COBAS 4800 BRAF V600 MUTATION TESTOWD2011-08-17
2020381561525136K961481ELECSYS 2010 ANALYZERJJE1996-06-14
2020381448151041K951595ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTESCGX1995-09-08
2020381585184467K100853COBAS 8000 MODULAR SERIES ANALYZERDCF2010-09-09
2020382020867859K082340ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYSCGN2009-06-19
1814381626770289
1855062004154678
1966731072368835
3348121147370834
2082001195856347
1433531213489159
2020381317542115
2020381367743876
1992561557491714
2020381567751279
1966731617339051
3348121671585948
1814381683353395
1433531848956967
1992561915203318
1966731921962980

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OWD12011-08-17
DCF12010-09-09
CGN12009-06-19
JJE11996-06-14
CGX11995-09-08