The following data is part of a premarket notification filed by Atlas Link Technology Co., Ltd. with the FDA for Atlas One Step Hcg Urine Pregnancy Test (strip), Atlas One Step Hcg Urine Pregnancy Test (cassette), Atlas One Step Hcg Urine Pregnancy Test (midstream).
| Device ID | K203246 |
| 510k Number | K203246 |
| Device Name: | Atlas One Step HCG Urine Pregnancy Test (Strip), Atlas One Step HCG Urine Pregnancy Test (Cassette), Atlas One Step HCG Urine Pregnancy Test (Midstream) |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | Atlas Link Technology Co., Ltd. Gu'an South Industry Zone Langfang, CN 065500 |
| Contact | Xiaoping Hao |
| Correspondent | Shuzhi Zang Atlas Link Technology Co., Ltd. Gu'an South Industry Zone Langfang, CN 065500 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-04 |
| Decision Date | 2021-08-04 |