PATHFAST®hs-cTnI-II
Phc Corporation
PHC Corporation
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9616263 | 3001229191 | PHC Corporation | 1 | N | 2027-01-01 | 1-1-1 Sakada, Oizumi-machi Ora-gun Gunma JP 370-0596 |
| 3004167884 | 3004167884 | PHC Corporation | 1 | N | 2027-01-01 | 110 OAZA-INOSHIRI-AZA-NISHIUENO WAKIMACHI MIMA Tokushima JP 779-3603 |
| 3029973107 | 3029973107 | PHC Corporation | 1 | N | 2027-01-01 | 1460-6 Aza-Mitodai, Mito Tako-machi Katori-gun Chiba JP 2892247 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 322509 | 2007394717 | K231974 | PATHFAST®hs-cTnI-II | MMI | 2024-03-20 |
| 21053 | 1067462821 | K122370 | CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR | NBW | 2013-09-26 |
| 21053 | 1352926715 | K110894 | CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER | LFR | 2012-03-28 |
| 322509 | 1946948066 | K100130 | PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2 | MMI | 2011-05-16 |
| 322509 | 1335012168 | K083412 | PATHFAST HSCRP | DCN | 2009-03-09 |
| 322509 | 1898051340 | K081360 | PATHFAST CK-MB-II, PATHFAST MYO-II | JHX | 2009-08-17 |
| 322509 | 1992291017 | K072288 | PATHFAST D-DIMER | GHH | 2009-05-06 |
| 322509 | 1713928158 | K072189 | PATHFAST NTPROBNP AND D-DIMER TESTS | NBC | 2008-02-05 |
| 140192 | 1586777350 | K013703 | SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175M | MQG | 2001-12-14 |
| 21053 | 1017045582 | ||||
| 140192 | 1163660323 | ||||
| 21053 | 1053560754 | ||||
| 21053 | 1210735036 | ||||
| 21053 | 1286490374 | ||||
| 21053 | 1290971780 | ||||
| 21053 | 1325165107 | ||||
| 21053 | 1339476361 | ||||
| 21053 | 1348535563 | ||||
| 21053 | 1365464794 | ||||
| 21053 | 1507758627 | ||||
| 322509 | 1690216506 | ||||
| 21053 | 1738971663 | ||||
| 21053 | 1907083385 | ||||
| 21053 | 1956011580 | ||||
| 140192 | 1962068537 |
Product Codes Associated With Registrations#
PMN#
GUDID#
PATHFAST Sample Diluent 1 - N/A
2025-04-18
PATHFAST Sample Diluent 2 - N/A
2025-04-18
PATHFAST - N/A
2023-06-12
PATHFAST cTnI-II - N/A
2016-09-22
PATHFAST Myo-II - N/A
2016-09-22
PATHFAST CK-MB-II - N/A
2016-09-22
PATHFAST D-Dimer - N/A
2016-09-22
PATHFAST NTproBNP - N/A
2016-09-22
PATHFAST hsCRP - N/A
2016-09-22
PATHFAST hs-cTnI-II - N/A
2024-05-01
PHCbi - This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity for the development of ova or embryos at or near Body temperature.
2018-04-25
PHCbi - This equipment is designed for low temperature storage of blood and blood products.
2018-04-25
PHCbi - This equipment is designed for low temperature storage of blood and blood products.
2018-04-25
PHCbi - This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity for the development of ova or embryos at or near Body temperature.
2018-04-25
Panasonic - This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity for the development of ova or embryos at or near Body temperature.
2016-09-24
Panasonic - This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity for the development of ova or embryos at or near Body temperature.
2016-09-24
Panasonic - This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity for the development of ova or embryos at or near Body temperature.
2016-09-24
Panasonic - This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity for the development of ova or embryos at or near Body temperature.
2016-09-24
Panasonic - This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity for the development of ova or embryos at or near Body temperature.
2016-09-24
Panasonic - This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity for the development of ova or embryos at or near Body temperature.
2016-09-24
PHCbi - This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity for the development of ova or embryos at or near Body temperature.
2018-04-25
PHCbi - This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity for the development of ova or embryos at or near Body temperature.
2020-04-09
PHCbi - This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity for the development of ova or embryos at or near Body temperature.
2019-11-15
Panasonic - This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity for the development of ova or embryos at or near Body temperature.
2017-10-02
Panasonic - This equipment is designed for low temperature storage of blood and blood products.
2016-09-24
Panasonic - This equipment is designed for low temperature storage of blood and blood products.
2016-09-24