FDA.reportPublic FDA data

R2 DIAGNOSTICS, INC.

Matched from indexed company URL: R2 CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
18353163000210416R2 DIAGNOSTICS, INC.1N2026-01-011801 COMMERCE DR. SOUTH BEND IN US 46628
30235355803023535580R2 DIGITAL MILLING TECHNOLOGIES1Y2026-01-0155 Bergenline Ave Unit A Westwood NJ US 07675
30250347813025034781R2 Technologies, Inc.1N2026-01-016517 Sierra Lane Dublin CA US 94568
30129016213012901621R2 TECHNOLOGIES, INC.1N2020-04-252603 Camino Ramon, Suite 200 San Ramon CA US 94583

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
524141083058313K781880ASSAY KIT, THROMBO-SCREENGIS1978-12-04
3113071883317811K213294Dermal Cooling SystemQPZ2022-11-10
2072071817878417K171398Dermal Cooling SystemGEH2017-07-06
2072071692826220K161480R2 Dermal Cooling SystemGEH2016-10-05
524141870241072K102908NOFACT IXGJT2011-12-19
524141569811790K102851NOFACT VIIIGJT2011-12-19
524141828472132K090105LUPOTEK KCTGGW2010-12-30
524141199482796K083878LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LAGIR2010-06-25
524142037189415K082631THROMBO TEK PSE, MODEL 90-480GGP2008-12-17
524141661085670K062306PLASMACON N, PLASMACON L-1, PLASMACON L-2GGC2007-03-16
524141830393663K050817T-TEKGJA2005-12-12
524141363524415K042919FIBROTEK FIBGIS2004-11-29
524141581059005K040296PHOSPHOPLASTIN RLGJS2004-05-24
524141602895455K033471PHOSPHOLIN ES AND CALCIUM CHLORIDEGGW2004-02-04
524141345511611
3119761001969086
3119761200380209
3119761251389692
3119761295133544
3119761687398989
3119761691295392

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEH22017-07-06
GJT22011-12-19
GGW22010-12-30
GIS22004-11-29
QPZ12022-11-10
GIR12010-06-25
GGP12008-12-17
GGC12007-03-16
GJA12005-12-12
GJS12004-05-24

NDC#

PMN#

T-TEK

2005-12-12

R2 DIAGNOSTICS, INC.

CA-1500

2004-01-22

R2 TECHNOLOGY, INC.