FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
MissLan Digital Pregnancy Rapid Test
K Number: K222305
·
Decision Nov 30, 2022
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
225
Applicant Total
8
Review Days
121
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Basic Information
- Device Name
- MissLan Digital Pregnancy Rapid Test
- K Number
- K222305
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Guangzhou Decheng Biotechnology Co., Ltd.
- Date Received
- August 1, 2022
- Decision Date
- November 30, 2022
- Product Code
- LCX
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LCX), ordered by most recent decision date.
MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test
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Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream
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FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream
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FDA Class 2
·Clinical Chemistry
iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Guangzhou Decheng Biotechnology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K251040 | MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test | Sep 9, 2025 | Substantially Equivalent |
| K250067 | Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro | Feb 20, 2025 | Substantially Equivalent |
| K242428 | Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus | Feb 6, 2025 | Substantially Equivalent |
| K240643 | MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream | Jun 21, 2024 | Substantially Equivalent |
| K240698 | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard | May 10, 2024 | Substantially Equivalent |
| K232659 | Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup | Dec 13, 2023 | Substantially Equivalent |
| K230038 | MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) | Feb 28, 2023 | Substantially Equivalent |