| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004577174 | 3004577174 | ARJ MEDICAL, LLC. / Gulf Coast Scientific, LLC. | 1 | Y | 2026-01-01 | 13812 Wright Cir Tampa FL US 33626 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 65782 | 1502757600 | P170022 | PyloPlus UBT System | OZA | 2020-02-18 |
| 65782 | 1106372919 | K052719 | URITEST 10 URINALYSIS REAGENT STRIPS | CDM | 2006-12-05 |
| 65782 | 1047883021 | K052708 | PYLO-PLUS | LYR | 2006-05-01 |
ARJ Medical Inc.209 State Street Eoldsmar, FL 34677 PMA NumberP170022 Supplement NumberS001 Date Received05/04/2022 Decision Date11/30/2022 Product Code OZA Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/co...
ARJ Medical Inc.
ARJ MEDICAL, INC.
ARJ MEDICAL, INC.
ARJ MEDICAL, INC.