Alltest Pregnancy Rapid Combo Test Cassette
FDA 510(k) K203272 · Hangzhou AllTest Biotech Co., Ltd.
510(k) numberK203272
Submission
- Device name
- Alltest Pregnancy Rapid Combo Test Cassette
- Applicant
- Hangzhou AllTest Biotech Co., Ltd.
Hangzhou, CN - Received
- November 6, 2020
- Decision date
- January 31, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JHI – Visual, Pregnancy Hcg, Prescription Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1155
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JHI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241919 | Innovita HCG Pregnancy Rapid Combo TestJHI · Traditional | Innovita (Tangshan) Biological Technology Co.… | 08/02/2024SE |
| K172322 | Atellica IM Total hCG (ThCG)JHI · Traditional | Siemens Healthcare Diagnostics, Inc. | 03/29/2018SE |
| K172257 | TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result…JHI · Traditional | True Diagnostics, Inc. | 12/22/2017SE |
| K152768 | Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy…JHI · Traditional | Assure Tech. Co., Ltd. | 02/24/2016SE |
| K130456 | Wunder Pregnancy TestJHI · Traditional | James Nguyen | 04/08/2014SE |
| K132834 | Fastep S10 HCG Serum/Urine Combo TestJHI · Traditional | Polymed Therapeutics, Inc. | 01/09/2014SE |
| K131166 | Sofia(R) HCG FiaJHI · Traditional | Quidel Corp. | 08/02/2013SE |
| K123844 | Chemtrue HCG Pregnancy Urine Dipstick, HCG Pregnancy Urine Cassette Test, and HCG Combo…JHI · Traditional | Chemtron Biotech, Inc. | 05/30/2013SE |
| K112101 | Fastep HCG Pregancy Serum/Urine Cassette and Dipstick TestsJHI · Traditional | Polymed Therapeutics, Inc. | 07/17/2012SE |
| K112315 | Home Pregnancy TestJHI · Traditional | Newscen Coast Bio-Pharmaceutical Co., Ltd. | 04/23/2012SE |
More from Newscen Coast Bio-Pharmaceutical Co., Ltd.
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| K251053 | Shinetell PlusTM Digital Early Pregnancy TestLCX · Traditional | 07/15/2025SE |
| K250727 | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test CupNFT · Traditional | 04/04/2025SE |
| K242576 | AllTest Viral Transport MediumJSM · Traditional | 04/04/2025SE |
| K244043 | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test CupNFT · Traditional | 02/27/2025SE |
| K242540 | AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test PanelNFT · Traditional | 09/27/2024SE |
| K241978 | Shinetell Digital Pregnancy TestLCX · Traditional | 08/13/2024SE |
| K241428 | AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test CupNFT · Traditional | 06/17/2024SE |
| K233019 | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest…DKZ · Traditional | 12/13/2023SE |
Questions and answers
When was Alltest Pregnancy Rapid Combo Test Cassette cleared by the FDA?
Alltest Pregnancy Rapid Combo Test Cassette (K203272) received a 510(k) decision of Substantially Equivalent on January 31, 2022, 451 days after the submission was received.
What is the product code of K203272?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.