← Back to catalogue
Egens One Step Hcg Urine Pregnancy Test Kit(s) (strip +2 more)
FDA 510(k)Class II (US FDA 510(k))
510(k) K123050
Identifiers
- 510(k) Number
- K123050 FDA 510(k)
- FDA Product Code
- LCX FDA 510(k)
- Models / Variants
- strip FDA 510(k)Cassette FDA 510(k)Midstream I And Midstream Ii FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1155 FDA 510(k)
- Regulation Number
- 862.1155 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Egens One Step Hcg Urine Pregnancy Test Kit(s) (strip +2 more) by Nantong Biotechnology Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 3 models
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123050 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nantong Biotechnology Co., Ltd.
Sources (1)
- FDA 510(k) K123050 24 fields · synced Jun 18, 2026