Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream)— 510(k) K203246
Substantially EquivalentAtlas Link Technology Co., Ltd.
FDA 510(k) clearance K203246 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), Substantially Equivalent on 2021-08-04. Applicant: Atlas Link Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Atlas Link Technology Co., Ltd.
- Product code
- Code LCX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Langfang, CN
Recent devices under product code LCX
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Data sourced from openFDA. This site is unofficial and independent of the FDA.