Atlas One Step HCG Urine Pregnancy Test (Strip), Atlas One Step HCG Urine Pregnancy Test (Cassette), Atlas One Step HCG Urine Pregnancy Test (Midstream)
Atlas Link Technology Co., Ltd.
Atlas Link Technology Co., Ltd.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3016849811 | 3016849811 | Atlas Link Technology Co., Ltd. | 1 | N | 2027-01-01 | Xing Min Road, South Industrial Park Langfang Hebei CN 065500 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 276503 | 1404561257 | K203246 | Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream) | LCX | 2021-08-04 |
| 276503 | 1937570284 | ||||
| 276503 | 2005593169 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LCX | 1 | 2021-08-04 |