Kyou Hee Lee
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3013735968 | 3013735968 | Kyou Hee Lee | 1 | N | 2026-01-01 | 14628 NW WENDY LN Portland OR US 97229 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 209741 | 2068079447 | K181551 | DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette | LCX | 2019-02-22 |
| 209741 | 1791680162 | K150022 | Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream | LCX | 2015-08-07 |
| 209741 | 1871971678 | K053236 | DAVID PREGNANCY TEST (MIDSTREAM) | LCX | 2006-07-18 |
| 209741 | 1960328061 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LCX | 3 | 2019-02-22 |